The widespread adoption of surgical stapling devices for gastrointestinal surgery is due to their ability to perform tissue transection, closure and anastomosis with a variety of operations. The use of these devices has increased with advancements made in both open and minimally invasive surgery. In each form of surgery, the quality of staple formation and how quickly the surgeon can handle the tissues are significant factors in choosing the appropriate type of stapler. Staplers come in two configurations; linear or circular, and each serves a specific purpose that will determine which one you should use based upon the location of the anastomosis, the operative procedure and the configuration of the anastomosis. While stapling may be able to simplify some forms of reconstruction, the success of the anastomosis is dependent upon many variables such as; tissue properties, vascularization, tension, choice of stapler, and proper technique when applying the stapler.1 A number of issues with a stapler can occur due to inadequate staple formation, failing to properly fire staples, inability to release or remove the stapling device, mechanical jamming, or other technical malfunctions while using it. Depending on what occurs, there could be need for extra suture placement, needing to use a stapler again, replacing the stapler device or changing the initial surgical plan. Kwazneski et al. (2013)2 have also pointed out the clinical implications of laparoscopic stapler failures as well as how technical issues can lead to changes in the way a surgeon conducts their operation. Makanyengo and Thiruchelvam (2020)3 recently did a review of the frequency and complications resulting from primary stapler failures. The authors indicated that variations in how primary device failures were defined resulted in varied estimates of these occurrences; and that many adverse-event reports do not provide adequate information regarding the nature of the problem experienced during the procedure. Internal-use surgical staples have been given much scrutiny in terms of their safety by federal regulators. Following reports of various adverse events to its devices, the FDA issued an advisory letter in 2019 to ensure proper selection and use of the device, to become familiar with the "IFU" or instructions for use provided with the product, and to be aware of possible complications that may arise from the use of these products. The FDA also developed a guidance document (Device Labelling) to address the labeling requirements for manufacturers of medical devices, as well as the required content for warnings, cautions, contraindications, precautions, and information about risk, limitation and proper use of such medical devices. These actions emphasize the need to document all technical occurrences during surgery that lead to corrective action taken during the course of surgery versus documentation of only post-operative complications as indicators of how well a device performed.4,5 Anastomotic leakage remains an important complication following gastrointestinal surgery and may lead to additional procedures, prolonged hospitalization, and substantial morbidity. Rahbari et al. (2010)6 proposed a standardized definition and grading system for anastomotic leakage following anterior rectal resection, illustrating the importance of consistent outcome definitions when comparing clinical studies. McDermott et al. (2015)7 reviewed preoperative, intraoperative, and postoperative factors associated with colorectal anastomotic leakage, while Sciuto et al. (2018)8 discussed the range of patient-related and procedural factors that influence leakage after laparoscopic colorectal surgery. Hernandez et al. (2021)9 further described the diagnostic challenges associated with anastomotic leakage and the role of clinical assessment, laboratory investigations, and imaging. Consequently, postoperative outcomes should be interpreted in the context of the underlying procedure and the criteria used to identify complications. Prospective observational studies offer an approach to documenting device performance under routine surgical conditions. Herzig et al. (2020)10 evaluated a powered circular stapler during left-sided colorectal surgery, demonstrating the value of recording intraoperative performance issues alongside postoperative outcomes. However, device-specific investigations do not necessarily represent the full range of technical difficulties encountered across gastrointestinal procedures, different stapler types, and varied operative approaches. Broader observational assessment may therefore complement device-specific evidence by describing the types of events encountered in routine clinical practice. The present study was undertaken to document intraoperative stapler-related technical events and early postoperative outcomes among patients undergoing gastrointestinal resection with stapled anastomosis at a single institution. The primary objective was to estimate the proportion of operations associated with at least one predefined technical event. Secondary objectives were to describe event categories, corrective measures, postoperative complications, unplanned intervention or reoperation, length of hospital stay, and 30-day readmission. The study also explored the distribution of technical events according to procedure category, surgical urgency, and operative approach. By considering intraoperative events and early outcomes together, the study sought to provide a descriptive account of stapler-related technical performance in routine surgical practice.

Study Setting and Design This prospective, single-centre observational study was designed to document intraoperative stapler-related technical events and early postoperative outcomes among patients undergoing gastrointestinal resection with stapled anastomosis. The study was conducted in the Department of General Surgery, Sambhram Institute of Medical Sciences and Research, Chaitanyapuram, Karnataka, India. The study involved routine surgical procedures performed according to the treating surgical team's clinical judgement. No additional intervention or alteration of the operative technique was mandated by the observational protocol. Eligible patients undergoing gastrointestinal resection with a stapled anastomosis were enrolled consecutively during the study period. Similar prospective observational approaches have been used to assess surgical stapler performance and associated clinical events, including the study by Herzig et al. (2020),10 which prospectively documented device-performance issues during left-sided colorectal surgery. Study Duration The study was conducted over eight months, from September 2021 to April 2022. Consecutive eligible patients undergoing gastrointestinal resection with stapled anastomosis during this period were considered for inclusion. Intraoperative variables were documented during the index operation, while postoperative outcomes were assessed during the hospital stay and through the specified 30-day postoperative follow-up period. Ethical Considerations The study was planned in accordance with the ethical principles outlined in the Declaration of Helsinki and applicable institutional requirements for research involving human participants.11 Approval from the Institutional Ethics Committee was documented before the study. Written informed consent was obtained from eligible participants before enrolment where required by the approved protocol. Sample Size Calculation The sample size was calculated using a single-proportion formula based on the 11.9% stapler-performance event rate reported by Herzig et al. (2020),10 with a 95% confidence level and 8% absolute precision. The estimated sample size was 63 patients, rounded to 65 patients for the study. Inclusion Criteria Patients were eligible for inclusion if they met all the following criteria: 1. Age 18 years or older. 2. Underwent gastrointestinal resection during the study period. 3. Had a stapled gastrointestinal anastomosis created during the index operation. 4. Were managed at the study institution. 5. Had sufficient operative documentation to establish whether a predefined intraoperative stapler-related technical event occurred. Both elective and emergency procedures were eligible. Open and minimally invasive operations were included, as were procedures involving linear staplers, circular staplers, or both. Exclusion Criteria Patients were excluded if they were less than 18 years old, did not undergo a procedure with a stapled GI anastomosis, or the operative documentation was inadequate to assess the initial outcome. Stapler use for skin closure or other uses related to but separate from the GI anastomosis were also ineligible. If a patient could not be followed up through all 30 days after surgery, patients were listed separately in the relevant complications instead of being categorized as having no complications. Primary Outcome The primary outcome was the proportion of operations in which at least one predefined intraoperative stapler-related technical event occurred. Events included incomplete firing, difficulty with device deployment, abnormal staple formation, difficulty releasing or removing the device, and device replacement because of a technical issue. The definition was intended to capture technical or performance events observed during the index operation and was broader than primary device malfunction alone.3 Each operation was classified as having or not having at least one event. The event type and corrective action were documented separately. Where multiple technical events occurred during one operation, the event-level recording procedure should follow the study data-collection form, while the primary outcome remains binary at the operation level. Secondary Outcomes Secondary outcomes included the distribution of technical-event categories, staple-line bleeding requiring intervention, anastomotic leak within 30 days, other major postoperative complications within 30 days, unplanned intervention or reoperation, length of hospital stay, and readmission within 30 days. Anastomotic leak was recorded as a postoperative outcome when documented in the clinical record within the 30-day observation period. The final study protocol should specify the clinical or radiological criteria used to identify a leak. Similarly, the term “other major complication” should be defined according to the actual study protocol and should not be assumed to represent a particular complication-grading system unless that system was applied consistently. Staple-line bleeding was recorded when it required intervention, rather than including all minor intraoperative oozing controlled by routine measures. Unplanned intervention or reoperation was recorded when an additional procedure was required beyond the planned index operation. Readmission was defined as an unplanned hospital admission within 30 days after the index procedure. Length of stay was measured in days from the index admission or operation to discharge, according to the convention used in the study records; the chosen reference point should be applied consistently. Study Variables Demographic variables included age and sex. Preoperative status was summarized using the American Society of Anaesthesiologists physical status classification. Operative variables included procedure category, surgical urgency, operative approach, and stapler type. Procedure categories included small-bowel resection, right colectomy, left or sigmoid colectomy, and low anterior resection. Surgical urgency was classified as elective or emergency, and the operative approach as open or minimally invasive. Stapler use was categorized as linear, circular, or both linear and circular. Intraoperative variables included the presence and category of a technical event and the corrective action recorded by the operating team. Postoperative variables included bleeding requiring intervention, anastomotic leak, other major complications, unplanned intervention or reoperation, length of hospital stay, and 30-day readmission. Variables were recorded using the study data-collection form and cross-checked against available operative and postoperative documentation. Procedures and Techniques Gastrointestinal resections and stapled anastomoses were performed by the surgical team according to established institutional practices. The choice of operative procedure, surgical approach, and stapling device was based on the clinical indication, anatomical considerations, patient condition, and surgeon preference. Linear staplers were used for tissue transection, closure, or anastomosis, as appropriate, while circular staplers were used for anastomoses where indicated. In procedures requiring both types of staplers, their use was recorded accordingly. All devices were operated in accordance with the manufacturer's instructions and routine surgical practice. Intraoperative stapler function was assessed by the operating surgeon. Any technical difficulty, including incomplete firing, deployment difficulty, abnormal staple formation, difficulty with device release or removal, or device replacement due to technical issues, was documented. These measures included additional suturing, repeat stapler application, device replacement, or other interventions considered necessary by the operating surgeon. Device selection and management of technical events were determined by clinical requirements and were not dictated by the study protocol. Postoperative care and monitoring followed routine institutional protocols. Postoperative complications, additional interventions, length of hospital stay, and readmissions were documented from hospital records and available follow-up information. Outcomes were assessed within 30 days of the index operation. Statistical Analysis Data were summarized using descriptive statistics. Continuous variables were reported as mean and standard deviation or median and interquartile range, as appropriate. Categorical variables were expressed as frequencies and percentages. The primary outcome was reported as a proportion with a 95% confidence interval. Fisher's exact test was used for selected categorical comparisons because of the small event counts. Length of hospital stay was compared between patients with and without a technical event using the Mann–Whitney U test. All tests were two-sided, and a p-value below 0.05 was considered statistically significant. Given the small number of technical events, subgroup analyses were considered exploratory; no multivariable prediction model was planned.

A total of 65 patients were included in the analysis. The mean age was 50.5 ± 14.4 years, with a range of 18–82 years, and 36 patients (55.4%) were male. Most patients belonged to ASA physical status class II (55.4%), followed by class III (32.3%). The demographic and preoperative characteristics are summarized in Table 1. Table 1. Demographic and preoperative characteristics (N = 65) Characteristic Value Age, years, mean ± SD 50.5 ± 14.4 Age range, years 18–82 Male, n (%) 36 (55.4) Female, n (%) 29 (44.6) ASA class I, n (%) 8 (12.3) ASA class II, n (%) 36 (55.4) ASA class III, n (%) 21 (32.3) Elective procedures accounted for 49 cases (75.4%), while 16 (24.6%) were performed as emergencies. An open operative approach was used in 41 patients (63.1%), and 24 (36.9%) underwent minimally invasive surgery. Left/sigmoid colectomy was the most frequent procedure category, followed by low anterior resection. Linear staplers were used in 37 cases (56.9%), while circular staplers were used in 21 (32.3%). The distribution of procedures and operative characteristics is presented in Table 2. Table 2. Operative and stapler characteristics Characteristic Category n (%) Procedure category Small-bowel resection 16 (24.6) Right colectomy 14 (21.5) Left/sigmoid colectomy 18 (27.7) Low anterior resection 17 (26.2) Surgical urgency Elective 49 (75.4) Emergency 16 (24.6) Operative approach Open 41 (63.1) Minimally invasive 24 (36.9) Stapler type Linear 37 (56.9) Circular 21 (32.3) Both linear and circular 7 (10.8) At least one predefined intraoperative stapler-related technical event was recorded in 5 of 65 cases (7.7%). The approximate Wilson 95% confidence interval for this proportion was 3.3%–16.6%, indicating considerable uncertainty around the estimated event frequency. The recorded events comprised incomplete firing, device deployment difficulty, abnormal staple formation, device release or removal difficulty, and device replacement due to a technical issue. Each category occurred once. The event distribution is shown in Table 3. Table 3. Intraoperative stapler-related technical events Event category n % of total cohort Incomplete firing 1 1.5 Device deployment difficulty 1 1.5 Abnormal staple formation 1 1.5 Device release/removal difficulty 1 1.5 Device replaced due to technical issue 1 1.5 Any technical event 5 7.7 No recorded technical event 60 92.3 Each event category was recorded once. Percentages use the full cohort as the denominator. The 95% confidence interval for any technical event was approximately 3.3%–16.6% (Wilson method). Anastomotic leak within 30 days was recorded in 4 patients (6.2%), while other major complications were recorded in 6 (9.2%). Staple-line bleeding requiring intervention occurred in 3 patients (4.6%). Four patients (6.2%) underwent an unplanned intervention or reoperation, and 4 (6.2%) were readmitted within 30 days. These outcomes were recorded separately and could overlap within individual patients. The postoperative outcome distribution is presented in Table 4. Table 4. Early postoperative outcomes Outcome Yes, n (%) No, n (%) Staple-line bleeding requiring intervention 3 (4.6) 62 (95.4) Anastomotic leak within 30 days 4 (6.2) 61 (93.8) Other major complication within 30 days 6 (9.2) 59 (90.8) Unplanned intervention or reoperation 4 (6.2) 61 (93.8) Readmission within 30 days 4 (6.2) 61 (93.8) Outcome categories are not mutually exclusive. Technical events were recorded in all four procedure categories. Two events occurred among 16 small-bowel resections (12.5%), while one event occurred in each of the other procedure categories. The observed proportions varied between procedures, but the small number of events limited the scope for meaningful comparative inference. The distribution is shown in Table 5. Table 5. Technical events according to procedure category Procedure category Total, n Events, n Event frequency, % Small-bowel resection 16 2 12.5 Right colectomy 14 1 7.1 Left/sigmoid colectomy 18 1 5.6 Low anterior resection 17 1 5.9 Total 65 5 7.7 Event frequency is calculated within each procedure category. No inferential test was performed for this table because of the small number of events. All five technical events occurred during elective procedures, compared with none among emergency procedures. Four events occurred during open surgery and one during minimally invasive surgery. Fisher’s exact test did not demonstrate a statistically significant association between technical-event occurrence and surgical urgency (p = 0.322) or operative approach (p = 0.644). These results should be interpreted cautiously because only five events were recorded. The comparisons are presented in Table 6. Table 6. Technical events according to surgical urgency and operative approach Characteristic Category Total, n Event, n (%) No event, n (%) p-value Surgical urgency Elective 49 5 (10.2) 44 (89.8) 0.322 Emergency 16 0 (0.0) 16 (100.0) Operative approach Open 41 4 (9.8) 37 (90.2) 0.644 Minimally invasive 24 1 (4.2) 23 (95.8) P-values were calculated using two-sided Fisher’s exact tests. Percentages for event and no-event categories are calculated within each subgroup. The small number of events limits the interpretation of these comparisons. The overall median length of hospital stay was 6 days (interquartile range [IQR], 5–7 days), with a range of 3–16 days. Median stay was also 6 days among patients with a technical event, compared with 6 days among those without a recorded event. The distributions did not differ significantly according to the Mann–Whitney U test (U = 155.5, p = 0.901). The no-event group had a wider IQR than the event group. These findings are summarized in Table 7. Table 7. Length of hospital stay according to technical-event status Group n Median, days IQR, days Range, days Mann-Whitney U Test Technical event 5 6.0 5.0–7.0 5–7 U = 155.5, p = 0.901 No technical event 60 6.0 4.0–7.25 3–16 Overall 65 6.0 5.0–7.0 3–16 Mann–Whitney U test comparing length-of-stay distributions between event and no-event groups. The test compares rank distributions and should not be interpreted as a test of medians alone.

The present study examined intraoperative stapler-related technical events and early postoperative outcomes in 65 patients undergoing gastrointestinal resection with stapled anastomosis. A technical event was recorded in 5 operations (7.7%; 95% confidence interval [CI], 3.3%–16.6%). There were also problems associated with the use of the stapler including: improper firing, difficulty in deploying staples, improperly formed staples, difficulty in releasing or removing the stapling apparatus, and/or replacing the device because of a malfunction. Complications included: 4 (6.2%) anastomotic leakages, 3 (4.6%) staple-line bleedings that required interventions, 6 (9.2%) other serious complications, 4 (6.2%) unplanned interventions/reoperations, and 4 (6.2%) readmissions at thirty days. These data provide information about both technical issues and post-operative consequences in a cohort of GI surgeries. They are not causal evidence of malfunctions of the stapling apparatus for complications after surgery. Herzig et al. (2020)10 evaluated a powered circular stapler in left-sided colorectal surgery and reported 22 device-performance issues among 168 anastomoses in 20 patients (11.9%). Only one complication was related to the procedure which caused complications that required re-attachment to the re-anastomosis, while anastomotic leakages were found after surgery in four of forty patients (2.4%) who had undergone surgery. Technical events, such as leaks or re-anastomoses were found in this population at the rate of 7.7%. While there is a clear quantitative difference in technical event rates between studies, this does not indicate that the devices used are superior for either group. Makanyengo and Thiruchelvam (2020)3 reviewed 12 studies reporting primary stapler malfunction and found incidence estimates ranging from 0.022% to 2.3% in observational studies. These estimates are lower than the 7.7% technical-event proportion in the present study, but the outcomes are not directly equivalent. The review focused on primary stapler malfunction, whereas the present study also recorded difficulties with deployment, staple formation, and device release or removal. The review also identified underreporting as a limitation in the available evidence. Similarly, Kwazneski et al. (2013)2 surveyed minimally invasive surgery programme directors and found that 86% of respondents had personal or peer experience with a linear stapler that failed to release or fire as intended. However, only 44 of 124 programme directors responded, and the survey measured reported experience rather than incidence in a defined patient cohort. These studies highlight the importance of distinguishing device malfunction from a broader category of intraoperative technical events. A study of 210 minimally invasive surgical cases reported device-related interruptions in 30% of cases, with laparoscopic staplers implicated in more than half of device failures. These findings support systematic documentation of intraoperative technical difficulties, although device-related interruptions are broader than stapler-specific events.12 Clapp et al. (2022)13 analysed stapler-related adverse events reported to the US Manufacturer and User Facility Device Experience (MAUDE) database for bariatric surgery between 2018 and 2020. They identified 883 reports involving Medtronic devices, 353 involving Ethicon devices, and 35 involving Intuitive devices. Based on estimated staple-reload use, the reported misfire rates were approximately 0.04% for Medtronic and 0.02% for Ethicon. Failure to fire was the most commonly reported event for both manufacturers. These estimates cannot be directly compared with the present study's 7.7% patient-level technical-event proportion because the reporting systems, denominators, populations, and event definitions differ. The findings nevertheless support recording the type of technical event rather than treating all stapler-related difficulties as a single interchangeable outcome. Anastomotic leakage was recorded in 4 of 65 patients (6.2%) in the present study. Parthasarathy et al. (2017),14 analysing 17,518 colorectal resections with anastomosis, reported a leakage rate of 3.9% (687 patients). Their analysis identified associations between leakage and several patient and procedural factors, including American Society of Anesthesiologists grade, sex, smoking, diabetes, serum albumin, and specific operative characteristics. The leakage proportion in the present study was numerically higher, but direct comparison is limited by the smaller sample and the inclusion of different gastrointestinal procedures and anastomotic locations. The four leakage events in this cohort are insufficient to establish whether the observed proportion reflects differences in case mix, baseline risk, or outcome ascertainment. A systematic review of 23 studies involving 110,272 patients identified low rectal anastomosis, male sex, and preoperative radiotherapy as potential risk factors for colorectal anastomotic leakage. This evidence reinforces the need to interpret the present leakage proportion in the context of patient characteristics and anastomotic location.15 Choi et al. (2006),16 in a study of 1,417 patients undergoing colorectal resection for malignancy, reported an anastomotic leakage rate of 1.8%. Higher ASA grade and emergency surgery were independently associated with leakage. These findings further emphasize the importance of patient risk and operative context when interpreting the 6.2% leakage proportion observed in the present mixed-procedure cohort. The definition of anastomotic leakage is also important when comparing studies. Rahbari et al. (2010)6 proposed a standardized definition and severity grading system for leakage after anterior rectal resection. Their classification distinguishes leaks according to the effect on clinical management, ranging from those requiring no change in management to those requiring re-laparotomy. Sciuto et al. (2018),8 in their review of leakage after laparoscopic colorectal surgery, also identified variation in definitions as a possible explanation for differences in reported rates. In the present study, leakage was identified from clinical records within 30 days. Unless the diagnostic criteria and severity grading were applied consistently, the observed 6.2% should be interpreted as the recorded leakage proportion rather than a directly standardized benchmark. Evidence comparing stapled and handsewn anastomoses provides additional context but addresses a different question. Choy et al. (2011)17 included seven trials involving 1,125 patients in a Cochrane review and reported leakage in 11 of 441 patients with stapled anastomoses and 42 of 684 with handsewn anastomoses; the pooled odds ratio was 0.48 (95% CI, 0.24–0.95; p = 0.03). Luglio and Corcione (2019)18 reported a related systematic review comprising six trials and 955 patients, with leakage in 5 of 357 patients receiving stapled anastomoses and 36 of 598 receiving handsewn anastomoses (odds ratio, 0.34; 95% CI, 0.14–0.82; p = 0.02). Both reviews found fewer leaks with stapled ileocolic anastomoses, while other reported outcomes did not differ significantly. These findings concern the comparison between anastomotic techniques, not the incidence or consequences of intraoperative stapler-related technical events. They therefore cannot establish whether the technical events recorded in the present cohort influenced postoperative leakage. Staple-line bleeding requiring intervention occurred in 3 patients (4.6%). Wang et al. (2022)19 evaluated a powered stapler using ex vivo porcine small-intestine segments and assessed tissue conditioning, burst pressure, and staple malformation. The maximum staple-malformation rate across the tested groups was 5.56%. Because this was an experimental study rather than a clinical cohort, its results cannot be used to estimate the incidence of bleeding or leakage in patients. The present bleeding proportion should instead be interpreted according to its clinical definition, which required intervention. Technical events occurred in 2 of 16 small-bowel resections (12.5%), 1 of 14 right colectomies (7.1%), 1 of 18 left or sigmoid colectomies (5.6%), and 1 of 17 low anterior resections (5.9%). All five events occurred during elective procedures; four occurred during open surgery and one during minimally invasive surgery. Fisher's exact tests did not identify statistically significant associations between event occurrence and urgency (p = 0.322) or operative approach (p = 0.644). With only five events, these comparisons are imprecise. The absence of events in emergency procedures should not be interpreted as evidence that emergency surgery carries a lower risk of technical events. The median hospital stay was 6 days overall and was also 6 days among patients with and without recorded technical events. The comparison did not identify a statistically significant difference (Mann–Whitney U = 155.5, p = 0.901). Given the small event group, this finding does not demonstrate equivalence between the groups or exclude a clinically important association. Length of stay may also reflect factors beyond stapler-related technical events, but the present study cannot establish their relative contributions. Strengths and Limitations The prospective observational design allowed intraoperative stapler-related technical events to be recorded alongside early postoperative outcomes. The inclusion of different gastrointestinal procedures, operative approaches, and stapler configurations provides a description of practice within the study setting. However, the single-centre design and small sample limit generalizability, and only five technical events were recorded, making subgroup comparisons imprecise. The mixed procedure categories and stapler configurations also limit direct comparison with device-specific studies. The study did not establish causal relationships between technical events and postoperative complications. In addition, reliance on clinical documentation for some postoperative outcomes may have resulted in incomplete ascertainment. Larger multicentre studies with standardized event definitions and consistent follow-up are required to clarify these findings.

In this prospective observational study, intraoperative stapler-related technical events occurred in 7.7% of 65 gastrointestinal operations involving stapled anastomosis. The recorded events included difficulties in firing, deployment, staple formation, device release, and device replacement. Anastomotic leakage, staple-line bleeding requiring intervention, and other postoperative complications were also observed. No statistically significant difference in length of hospital stay was identified between patients with and without recorded technical events. The findings provide a descriptive account of stapler-related technical events in routine surgical practice but do not establish causality. Larger multicentre studies with standardized definitions and consistent follow-up are warranted.

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