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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. This notice concerns these specific reloads; it does not describe a recall of every SureForm stapler or of SP SureForm 45 reloads.[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, but does not prove inherent safety superiority
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

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/maximum compressed tissue thickness. Its example cartridge tables are examples, not a universal operating protocol.[2]

Historical absorbable-staple studies used particular devices and materials. They do not establish that an absorbable reload is currently available or compatible with a modern endoscopic or robotic stapler.

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/tissue, provide adequate exposure, and plan control of major bleeding before firing.

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. These findings do not make the risk zero or establish en-bloc stapling as appropriate for every nephrectomy, particularly donor surgery where preservation of individual vessels matters.[3] In a separate series, 428 patients represented 433 renal units and only 70% had postoperative imaging; “no detected fistula” is not proof of complete lifelong surveillance.[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. Such comparisons cannot establish safety equivalence for catastrophic events or remove this contraindication. Historical cost and vessel-length advantages do not justify contraindicated use.[6]

Failure reports​

A review identified 383 reported stapler complications during minimally invasive nephrectomy in the FDA MAUDE database. These are reports, not the denominator of exposed operations. The absence of deaths or reoperations among reported TA events cannot establish a lower complication rate or inherent safety superiority over another device.[7]

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​

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; the trial was not large enough to establish equivalence for rare catastrophic events. 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. The choice between stapled and hand-sewn reconstruction depends on the bowel, operative circumstances and expertise; a particular stapler length does not determine safe anastomosis.

A 170-patient RARC/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. This uncontrolled experience describes outcomes; it does not show that the stapler caused lower complication rates.[9]

A retrospective comparison of GIA-60 and GIA-80 in 511 evaluable cystectomy patients found no independent association between stapler size and ileus. This is not proof that anastomotic geometry never matters, nor a basis for selecting a device irrespective of bowel dimensions.[10]

Higher-level evidence — scope matters​

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; it does not establish a circular-stapler stricture effect or prove superiority for every ileo-ileal anastomosis in urinary reconstruction.[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. These findings should not be generalized either as proof that all absorbable staples are harmful or as support for routine absorbable-stapled reconstruction.[12]

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. Its reported 60-month continence results should not be read as outcomes measured in all 606 men, or as a randomized comparison with hand sewing.[13]

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). Selection, operative technique and other confounding remain possible. These data support discussing reservoir construction and urinary staple exposure; they do not establish that staples independently cause impaired continence or that one configuration is universally preferable.[14]

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. “Buried” or titanium staples cannot be assumed to eliminate the risk.

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. This is a small, device- and technique-specific study, not evidence for substituting an unapproved absorbable cartridge in today's system.[15]

The Mastroianni cohort and other small observational comparisons also raise concern about stones after stapled reservoir construction, but do not define a universal percentage or an identical surveillance schedule for every patient.[14] Use the lifelong follow-up appropriate to the diversion and investigate recurrent infection, hematuria, obstruction or other stone symptoms.

Part VI: Other Urologic Applications​

Older reports of stapled urinary tissue closure are useful historical context; they are not routine procedural recommendations:

ApplicationEvidence boundary
Stapled bladder cuffEarly animal and three-patient feasibility work does not establish oncologic adequacy or contemporary acceptance. 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; this cannot establish freedom from stones.[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. This is preclinical work, not a ready clinical alternative to a vascularized flap.[18]
Tapered catheterizable ileumAn early ten-patient series included five stapled and five clamp-tapered segments. Its total outcomes cannot be attributed to ten stapled channels.[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. Most reported deaths occurred postoperatively, but the database cannot supply a population incidence or prove which device caused an individual event.[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. No fluorescence image, negative leak test or completed-fire message alone guarantees healing.

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.
  • Separate intestinal and urinary questions: a safe bowel anastomosis does not validate a stapled urinary reservoir.
  • 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. 2025. 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. 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.

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