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Staplers in Urologic Surgery

Staplers are used for selected vascular control, bowel division and intestinal anastomosis steps. Stapling a urinary reservoir or closing urinary tissue is a different application: exposed material, reservoir geometry and long-term function need separate consideration. Device and reload selection must follow the exact current instructions for use, not a universal color or staple-height table.

2026 FDA recall — specific SureForm 30 gray reloads

The FDA classified the recall of 8 mm SureForm 30 gray reloads, part numbers 48230M-05 and 48230M-06, as Class I on May 5, 2026. Affected reloads can leave incomplete staple lines on blood vessels despite a completed-fire message. Identify, stop use and quarantine affected products, following the recall instructions. As of February 23, 2026, Intuitive Surgical had reported four serious injuries and one death; the resulting bleeding may require conversion to open surgery, and the company recommends alternative options.[1]

Part I: Stapler Types and Fundamental Mechanics​

Device familyMechanismImportant distinction
Linear cutter / GIA-typePlaces staple lines and divides the tissue between themNumber of rows, length, staple geometry and tissue limits vary by model
Linear non-cutting / TA-typePlaces a staple line without an integrated cutting stepSeparate division permits an additional assessment
Circular staplerCreates a circular staple line with tissue cuttingUsed for appropriate intestinal anastomoses; size, tissue rings and integrity assessment are procedure-specific
Endoscopic or robotic systemProvides a minimally invasive delivery and actuation platformA bedside powered stapler is distinct from a console-controlled robotic instrument

A linear cutter places staple rows on both sides of the intended division and cuts between them in one firing; row count and arrangement vary by model.[2] A non-cutting linear stapler places the staple line only, and the surgeon divides the tissue with a knife or scissors. Vascular reloads have shorter staples than tissue reloads; a typical manufacturer range is about 2.0–2.5 mm for vascular and 3.5–4.8 mm for tissue cartridges, and cartridge lengths commonly run 30, 45, 60 and 80 mm. Treat these as orientation values and confirm them in the labeling for the model in hand. Absorbable (polyglyconate) staples for a GIA-type instrument became available in 1992 and were then incorporated into stapled orthotopic reservoirs.[21]

Open staple height and closed staple height are different measurements. Cartridge colors, tissue names and nominal heights cannot be transferred between product lines. FDA guidance recommends labeling that specifies compatible components, intended tissues and minimum and maximum compressed tissue thickness.[2]

Part II: Vascular Pedicle Control​

Renal-hilum control​

Vascular stapling is one approach to renal-vessel control. Select a device and reload labeled for the intended vessel or tissue, provide adequate exposure, and plan control of major bleeding before firing. In one donor-nephrectomy series (371 arteries in 276 donors), bleeding at the stapled artery stump was more frequent for arteries 3 mm or smaller (p = 0.01). In experimental porcine arteries, incomplete staple formation was common at 3 mm. Inspect small-artery staple lines and prepare supplemental hemostasis.[40]

En-bloc hilar stapling: a 2017 review identified nine studies with 595 patients; no arteriovenous fistula was diagnosed at an average 26.5 months. Only four studies contributed comparative data.[3] A retrospective series of 161 laparoscopic nephrectomies (90 en bloc, 71 individual vessel stapling) found no clinical evidence of arteriovenous fistula at a mean 34 months.[22] In a double-institution series of 428 patients (433 renal units), no clinical or radiographic arteriovenous fistula was found at a mean follow-up of 51 months; 70% had postoperative imaging.[4]

Staplers and clips are not interchangeable​

Hem-o-lok ligating clips are contraindicated for ligating the renal artery during laparoscopic donor nephrectomy. This remains explicit in FDA-cleared labeling. Choose a method appropriate for the vessel and procedure under its current instructions.[5]

A meta-analysis of eight observational studies found no statistically significant differences in several rare adverse outcomes between clips and staplers.[6]

Failure reports​

A review of FDA MAUDE reports from January 2009 through August 2019 identified 383 reported stapler complications during minimally invasive radical nephrectomy (63% Ethicon endocutters, 28% Endo GIA, 9% Endo TA), including 22 deaths (5.7% of reports); no deaths or reoperations occurred due to TA staplers in these reports. Apart from one device, manufacturer evaluation of returned devices found no abnormality or attributed the fault to improper use.[7]

In a two-institution series of 565 laparoscopic nephrectomies, the endovascular stapler malfunctioned in 10 (1.7%). The renal vein was involved in 8 and the artery in 2. Two cases (20%) needed open conversion, and 7 of the 10 malfunctions had a preventable cause. Failures recognized before the device was released were often managed laparoscopically.[23]

Avoid forcing the jaws around excessive tissue, hidden clips or an inadequately exposed vessel. When practical, provide proximal control before transection and be prepared for an incomplete staple line, bleeding or a device that will not release. Follow the specific troubleshooting instructions rather than improvising a repeat fire.[2]

Radical cystectomy pedicles​

Stapled pedicle control has been described for cystectomy and prostatectomy. In a randomized trial of 70 patients, an articulating linear cutter lowered estimated blood loss and transfusion requirement compared with suture ligation, with no stapler-attributable complications.[24] A 16-patient series using a multifire Endo-GIA reported less blood loss and shorter operative time than 23 conventional cases.[25] In a 21-patient prostatectomy series, the vascular stapler was used on the dorsal vein complex and lateral pedicles (mean operative time 2 hours, blood loss about 400 mL).[26]

An 80-patient randomized comparison of Endo GIA and Impact LigaSure found no statistically significant difference in blood loss or transfusion requirements. The study's lower local device cost for LigaSure was an institution- and era-specific result. Device choice also depends on anatomy, labeling and the available means of rescue.[8]

Part III: Bowel Division and Reanastomosis​

Stapled side-to-side intestinal anastomosis is an established option after bowel harvest for urinary diversion. A 2026 synthesis of four retrospective cystectomy studies (529 patients) found no statistically significant difference in gastrointestinal complications versus hand-sewn anastomosis (OR 1.13, 95% CI 0.66–1.93); differences in oral intake and flatus were less than one day and of uncertain clinical relevance.[41] The choice between stapled and hand-sewn reconstruction depends on the bowel, operative circumstances and expertise.

A 170-patient RARC and diversion cohort reported postoperative ileus in 7.0%, small-bowel obstruction in 4.7% and no intraoperative bowel injuries with its stapled ileo-ileal technique.[9]

A retrospective comparison of GIA-60 and GIA-80 in 511 evaluable cystectomy patients found no independent association between stapler size and ileus.[10] In a multicenter randomized trial of 78 cystectomy patients receiving an ileal conduit, postoperative ileus occurred in 24% after two robotic EndoWrist 45-mm firings versus 3% with a handheld EndoGIA 60-mm stapler; hospital stay was 13 versus 8 days. Bowel Function Index scores did not differ through 12 months.[39]

An early series of 110 ileal conduits built with stapling devices reported shorter operative time and less postoperative morbidity than conventional suture construction. It is historical and uncontrolled.[27]

Higher-level evidence — scope matters​

A multicenter randomized trial of 440 right hemicolectomies for carcinoma compared four hand-sewn techniques with a side-to-side GIA plus TA anastomosis. Leakage occurred in 2.8% of stapled versus 8.3% of all hand-sewn anastomoses combined.[28]

The Cochrane review of linear-cutter ileocolic anastomosis, searched through December 2010, included seven trials with 1,125 participants. Leaks occurred in 11/441 stapled versus 42/684 hand-sewn anastomoses (OR 0.48, 95% CI 0.24–0.95). Other assessed outcomes were not significantly different. This review concerns ileocolic anastomosis, with much evidence from cancer surgery.[11]

Part IV: Neobladder and Reservoir Construction​

Staples used to restore bowel continuity should be distinguished from staples that remain in the urinary reservoir. Reservoir shape, compliance, outlet configuration, tissue preservation and urinary exposure may all affect outcomes.

A. Historical absorbable-stapled reservoirs​

Early series demonstrated feasibility, but results were configuration-specific. In Montie's later comparative experience, 6 of 19 W-stapled reservoirs had unsatisfactory characteristics: three required augmentation and three had small, higher-pressure reservoirs.[12]

The related reports:

  • W-stapled ileal neobladder (Montie 1994): 15 patients; reservoir construction took 12–21 minutes, and urodynamics and continence appeared comparable to other ileal reservoirs. The authors called for comparative trials.[21]
  • Pediatric right-colon pouches (Kirsch 1996): 18 children (8 continent diversions, 10 colocystoplasties). Absorbable staples shortened operative time by about 1 hour and saved about $350 per case. One pouch ruptured late and there were no reservoir stones at up to 3 years.[29]
  • All-stapled colonic reservoir (Parra 1991): 27 patients (17 men, 10 women); mean construction time 95.4 minutes, continence in all but 1 at a mean 22.8 months, mean capacity 750 mL at 8.1 cm H2O filling pressure.[30]

B. Titanium-stapled reservoirs​

Muto's 2016 report described 606 men receiving a particular stapled orthotopic neobladder over a long institutional experience. It supports feasibility and provides long-term observational follow-up.[13] In that series, median operative time was 205 minutes, and at 60 months daytime and nighttime continence were complete in 96% and 72% of the men assessed. Early complications occurred in 24% and late complications in 23%.

Other titanium-stapled techniques have been described. In a 43-man GIA-stapled Camey II neobladder series with serosa-lined antireflux ureteroileal implantation, construction of the neobladder and ureteral anastomoses took about 1 hour 45 minutes. Over a median follow-up of 38 months, the authors reported one case of neovesico-ureteral reflux and two ureteroileal anastomotic strictures (reported complication rate 6.9%).[31] A laparoscopic-assisted U-shaped neobladder built with nonabsorbable titanium staples was reported as a technical description.[32] In a retrospective comparison of 55 laparoscopic cystectomies, stapler construction was faster than manual suturing, functional outcomes were comparable, and 2 of 30 stapled neobladders developed stones versus none of 25 sutured.[33]

C. Stapled vs. hand-sewn intracorporeal neobladder​

Mastroianni 2025 was a retrospective, single-center comparison, not a randomized trial: 116 patients treated during 2018–2023, including 60 hand-sewn and 56 stapled neobladders. The hand-sewn group had a lower stone rate and better unadjusted continence recovery; perioperative outcomes were similar apart from length of stay.[14]

The adjusted findings require care. In the whole cohort, sex-sparing surgery was the only independent predictor of continence recovery. After excluding sex-sparing procedures, hand sewing was associated with nighttime continence recovery (HR 2.6, 95% CI 1.27–5.34).[14] Selection, operative technique and other confounding remain possible.

Part V: Urinary Staple Exposure and Stones​

Exposed foreign material can become a nidus for encrustation. Stone risk also depends on urinary stasis, infection, mucus and metabolic factors.

In a review of 30 patients (mostly children) with bowel interposed in the urinary tract during reconstruction, stones formed on staples in 8. The staple sat eccentrically in the calcified stone, which is a useful radiographic clue.[34] Sutures in contact with urine can serve as a stone nidus, and absorbable sutures are preferred for urinary-tract closure; the same reasoning is applied to staples.[35] Controlled staple data are limited to a few small studies. Keep staple lines buried under mucosa where possible.

Two exposed-staple observations are reassuring but limited. A titanium staple line left in the bladder after laparoscopic nephroureterectomy showed no encrustation at 6 months; it was removed cystoscopically without sequelae.[36] In 104 stapled dog-bladder closures with stainless-steel or absorbable staples, exposed staples were common with the absorbable type (29 closures) and rare with steel (4), crystals formed in only 3 closures, and all closures healed.[37]

An older randomized hemi-Kock pouch trial assigned 50 patients to absorbable or nonabsorbable staples for a particular antireflux valve. Among 41 evaluable patients, pouch stones occurred in 1/21 versus 6/20, respectively.[15]

The Mastroianni cohort and other small observational comparisons also raise concern about stones after stapled reservoir construction.[14] Use the lifelong follow-up appropriate to the diversion and investigate recurrent infection, hematuria, obstruction or other stone symptoms. If nonabsorbable staples remain in contact with urine, plan periodic imaging for stones.

Part VI: Other Urologic Applications​

ApplicationEvidence boundary
Stapled bladder cuffEarly animal and three-patient feasibility work has been reported. Bladder-cuff management must satisfy the complete oncologic procedure.[16]
Reduction pyeloplastyFive stapled cases were compared with 12 sutured cases. No symptomatic stones were reported, but only two stapled patients had imaging directed at stone detection.[17]
Stapled Boari-like tubeA 14-pig experiment lost two animals to pneumonia; among the remaining animals, three developed hydronephrosis, including two with renal atrophy.[18]
Tapered catheterizable ileumAn early ten-patient series included five stapled and five clamp-tapered segments.[19]

Part VII: Recognizing and Managing Stapling Failure​

FDA labeling guidance emphasizes tissue suitability, compatible components, visibility and preparation for failure.[2] A larger MAUDE study identified 676 death reports associated with stapler or clip-applier devices over 24 years.[20] Most reported deaths occurred postoperatively.[20]

Before firing, assess tissue condition, thickness, alignment and tension; exclude unintended structures and follow the labeled compression sequence. After firing, inspect staple formation, division and hemostasis. For an intestinal anastomosis, add the integrity and perfusion assessment appropriate to the site and technique.

A 2025 review of colorectal stapling failures reported an incidence of 0.02% to 2.3%. Mechanical failures include misfires, jamming and lockups; technical failures include misalignment, crossed staple lines and poor tissue selection. Listed risk factors are obesity, diabetes, pelvic surgery, emergency operations and inadequate mobilization. The authors describe a four-part intraoperative assessment (the Wexner quadruple assessment) to detect stapling misadventures early. Management depends on the failure and includes reinforcing sutures, anastomotic revision or diversion.[38]

Practical Selection Checklist​

  • Exact device and reload: current intended use, compatibility, tissue limits, expiry, firing allowance and relevant recalls.
  • Suitable tissue and exposure: do not force a cartridge onto thick, friable or ischemic tissue outside its instructions.
  • A failure plan: immediate vascular control or repair, alternative instruments and a trained team.
  • Evidence in context: distinguish randomized trials, retrospective comparisons, single-arm technique reports, animal experiments and surveillance reports.

See Also​

References​

1. US Food and Drug Administration. “Surgical Stapler Reload Recall: Intuitive Surgical Removes 8mm SureForm 30 Gray Reloads.” Updated May 5, 2026. FDA safety communication.

2. US FDA. Surgical Staplers and Staples for Internal Use — Labeling Recommendations. October 8, 2021. Guidance.

3. Lai WS, Rais-Bahrami S. "Safety and efficacy of en bloc renal hilar vascular staple ligation: a meta-analysis." J Urol. 2017;197(1):175–181. doi:10.1016/j.juro.2016.07.077

4. Sherer BA, Chow AK, Newsome MJ, et al. "En bloc stapling of the renal hilum during laparoscopic nephrectomy: a double-institutional analysis of safety and efficacy." Urology. 2017;105:69–75. doi:10.1016/j.urology.2017.01.051

5. US Food and Drug Administration. Hem-o-lok Ligating Clips, K232970. January 12, 2024. Section G: contraindications. FDA 510(k) summary.

6. Liu Y, Huang Z, Chen Y, et al. "Staplers or clips? A systematic review and meta-analysis of vessel controlling devices for renal pedicle ligation in laparoscopic live donor nephrectomy." Medicine (Baltimore). 2018;97(45):e13116. doi:10.1097/MD.0000000000013116

7. Gopal N, Long B, Phillips J, Eshghi M. "Endovascular stapler complications during minimally invasive nephrectomy: an updated review of the FDA MAUDE database from 2009–2019." Urology. 2021;153:181–184. doi:10.1016/j.urology.2021.02.010

8. Thompson IM, Kappa SF, Morgan TM, et al. "Blood loss associated with radical cystectomy: a prospective, randomized study comparing Impact LigaSure vs. stapling device." Urol Oncol. 2014;32(1):45.e11–e15. doi:10.1016/j.urolonc.2013.06.006

9. Saxena S, Kim K, Billah MS, et al. "Outcomes of stapled ileo-ileal anastomosis during robot-assisted radical cystectomy with urinary diversion: points of technique." J Endourol. 2026;40(1):48–53. doi:10.1177/08927790251390881

10. Ghanaat M, Winer AG, Sjoberg DD, et al. "Comparison of postradical cystectomy ileus rates using GIA-80 versus GIA-60 intestinal stapler device." Urology. 2018;122:121–126. doi:10.1016/j.urology.2018.09.010

11. Choy PY, Bissett IP, Docherty JG, et al. "Stapled versus handsewn methods for ileocolic anastomoses." Cochrane Database Syst Rev. 2011;(9):CD004320. doi:10.1002/14651858.CD004320.pub3

12. Montie JE, Pontes JE, Powell IJ. "A comparison of the W-stapled ileal reservoir with hand-sewn reservoirs for orthotopic bladder replacement." Urology. 1996;47(4):476–481. doi:10.1016/S0090-4295(99)80480-4

13. Muto G, Collura D, Simone G, et al. "Stapled orthotopic ileal neobladder after radical cystectomy for bladder cancer: functional results and complications over a 20-year period." Eur J Surg Oncol. 2016;42(3):412–418. doi:10.1016/j.ejso.2015.11.010

14. Mastroianni R, Chiacchio G, Tuderti G, et al. "Stapled vs totally handsewn robotic intracorporeal neobladder: perioperative and functional outcomes." BJU Int. 2025;136(5):866–871. doi:10.1111/bju.16826

15. Arif H, Madbouly K, Mahran MR, Ashamallah A, Ghoneim MA. "A prospective randomized study comparing absorbable and nonabsorbable staples in constructing antireflux valves of urethral hemi-Kock pouches." BJU Int. 1999;84(4):440–443. doi:10.1046/j.1464-410x.1999.00211.x

16. Kerbl K, Chandhoke P, McDougall E, et al. "Laparoscopic stapled bladder closure: laboratory and clinical experience." J Urol. 1993;149(6):1437–1440. doi:10.1016/s0022-5347(17)36408-x

17. Grubb RL, Sundaram CP, Yan Y, et al. "Use of titanium staples during upper tract laparoscopic reconstructive surgery: initial experience." J Urol. 2002;168(4 Pt 1):1366–1369. doi:10.1016/S0022-5347(05)64450-3

18. Gallentine ML, Harmon WJ. "Ureteral substitution with a stapled neoureter: a simplified Boari flap." J Urol. 2001;166(5):1869–1872. doi:10.1016/s0022-5347(05)65709-6

19. Bejany DE, Politano VA. "Stapled and nonstapled tapered distal ileum for construction of a continent colonic urinary reservoir." J Urol. 1988;140(3):491–494. doi:10.1016/s0022-5347(17)41699-5

20. Reddy BN, Subhash M, Vangel M, et al. "Mortality related to the use of stapler devices and clip appliers: analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience database." Surgery. 2023;173(5):1184–1190. doi:10.1016/j.surg.2022.11.013

21. Montie JE, Pontes JE, Parulkar BG, Selby T. "W-stapled ileal neo-bladder formed entirely with absorbable staples." J Urol. 1994;151(5):1188–1192. doi:10.1016/s0022-5347(17)35210-2

22. Kouba E, Smith AM, Derksen JE, Gunn K, Wallen E, Pruthi RS. "Efficacy and safety of en bloc ligation of renal hilum during laparoscopic nephrectomy." Urology. 2007;69(2):226–229. doi:10.1016/j.urology.2006.09.046

23. Chan D, Bishoff JT, Ratner L, Kavoussi LR, Jarrett TW. "Endovascular gastrointestinal stapler device malfunction during laparoscopic nephrectomy: early recognition and management." J Urol. 2000;164(2):319–321. doi:10.1016/s0022-5347(05)67349-1. PMID 10893574

24. Chang SS, Smith JA Jr, Cookson MS. "Decreasing blood loss in patients treated with radical cystectomy: a prospective randomized trial using a new stapling device." J Urol. 2003;169(3):951–954. doi:10.1097/01.ju.0000051372.67213.ca

25. Hanash KA, Peracha AM, Al-Zahrani HM, et al. "Radical cystectomy: minimizing operative blood loss with a 'stapling technique'." Urology. 2000;56(3):488–491. doi:10.1016/s0090-4295(00)00582-3

26. Gould DL, Borer J. "Applied stapling technique in radical retropubic prostatectomy: efficient, effective and efficacious." J Urol. 1996;155(3):1008–1010. doi:10.1016/s0022-5347(01)66370-5. PMID 8583548

27. Karamcheti A, O'Donnell WF, Hakala TR, Schwentker FN, Steichen FM. "Autosuture ileal conduit construction: experience in 110 cases." J Urol. 1978;120(5):545–548. doi:10.1016/s0022-5347(17)57268-7

28. Kracht M, Hay JM, Fagniez PL, Fingerhut A. "Ileocolonic anastomosis after right hemicolectomy for carcinoma: stapled or hand-sewn? A prospective, multicenter, randomized trial." Int J Colorectal Dis. 1993;8(1):29–33. doi:10.1007/BF00341273

29. Kirsch AJ, Olsson CA, Hensle TW. "Pediatric continent reservoirs and colocystoplasty created with absorbable staples." J Urol. 1996;156(2 Pt 2):614–617. doi:10.1016/S0022-5347(01)65763-X

30. Parra RO. "A simplified technique for continent urinary diversion: an all-stapled colonic reservoir." J Urol. 1991;146(6):1496–1499. doi:10.1016/s0022-5347(17)38149-1

31. Muto G, Bardari F, D'Urso L. "New serosal lined antireflux ureteroileal implantation technique on a GIA stapler detubularised ileal neobladder: technical considerations and results." Eur Urol. 2005;48(5):826–830. doi:10.1016/j.eururo.2005.03.011

32. Abreu SC, Araújo MB, Silveira RA, et al. "Laparoscopic-assisted radical cystectomy with U-shaped orthotopic ileal neobladder constructed using nonabsorbable titanium staples." Urology. 2006;68(1):193–197. doi:10.1016/j.urology.2006.02.011

33. Shao P, Li P, Ju X, et al. "Laparoscopic radical cystectomy with intracorporeal orthotopic ileal neobladder: technique and clinical outcomes." Urology. 2015;85(2):368–373. doi:10.1016/j.urology.2014.09.059

34. Dangman BC, Lebowitz RL. "Urinary tract calculi that form on surgical staples: a characteristic radiologic appearance." AJR Am J Roentgenol. 1991;157(1):115–117. doi:10.2214/ajr.157.1.2048508

35. Edlich RF, Rodeheaver GT, Thacker JG. "Considerations in the choice of sutures for wound closure of the genitourinary tract." J Urol. 1987;137(3):373–379. doi:10.1016/s0022-5347(17)44038-9

36. Baughman SM, Sexton W, Bishoff JT. "Multiple intravesical linear staples identified during surveillance cystoscopy after laparoscopic nephroureterectomy." Urology. 2003;62(2):351. doi:10.1016/s0090-4295(03)00335-2

37. Julian TB, Ravitch MM. "Closure of the urinary bladder with stainless steel and absorbable staples." Ann Surg. 1986;204(2):186–192. doi:10.1097/00000658-198608000-00014

38. Emile SH, Dourado J, Salama E, Boutros M, Wexner SD. "A comprehensive review of the types and management of stapling failures in colorectal surgery." Surgery. 2025;188:109720. doi:10.1016/j.surg.2025.109720

39. Bak R, Fabrin K, Jensen TK, et al. "Comparison of the EndoGIA versus the Endowrist stapler in intracorporeal urinary diversion in robotic assisted radical cystectomy (EGIAES) - a randomized multicentre trial." J Robot Surg. 2026;20(1):51. doi:10.1007/s11701-025-03009-6

40. Kaku K, Kubo S, Hisadome Y, Noguchi H, Nakamura M. "Evaluation of automatic staplers for renal artery division in laparoscopic donor nephrectomy: impact of vessel diameter on hemostatic outcomes." Surg Endosc. 2025;39(11):7546–7554. doi:10.1007/s00464-025-12115-3

41. Abdelshafi A, Mohamed T, Mohamed H, et al. "Hand-sewn versus stapled ileo-ileal anastomosis following radical cystectomy: A systematic review and meta-analysis." Urol Oncol. 2026;44(7):215–224. doi:10.1016/j.urolonc.2026.04.009