Robotic Stapler (da Vinci)
A robotic stapler gives the console surgeon control of positioning, clamping and firing. A trained bedside team is still needed for loading, exchanges, troubleshooting and emergency access. Console control alone does not prove better staple formation or fewer complications than a bedside laparoscopic stapler.
The FDA's May 2026 Class I recall concerns 8 mm SureForm 30 gray reloads 48230M-05 and 48230M-06. Affected reloads may leave an incomplete vessel staple line despite a completed-fire message. Stop use and quarantine affected stock according to the recall instructions. This is not a recall of every SureForm model.[1]
Current Platform Distinctions
Manufacturer US specifications distinguish the following systems; the exact instrument's instructions control compatibility and use.[2]
| Stapler | Platform | Access | Staple rows |
|---|---|---|---|
| SureForm 30 | Da Vinci 5, X or Xi | 8 mm cannula or compatible 12–8 mm reducer | Four |
| SureForm 45 or 60 | Da Vinci 5, X or Xi | 12 mm cannula | Six |
| SP SureForm 45 | Da Vinci SP only | Advanced Access Port | Six |
These SureForm instruments are single-patient devices with a manufacturer limit of 12 fires per device. SmartFire monitors compression before and during firing. The described 120° cone of articulation is not a universal 90° specification for every generation of robotic stapler. A completion message cannot replace inspection of the actual tissue and staple line.[2][1]
Use in Reconstructive Urology
A stapler may be used for selected bowel division and anastomosis steps during urinary diversion or other reconstruction. Described uses include the stapled ileo-ileal anastomosis in robotic cystectomy with diversion, ileal-conduit construction (bowel division, side-to-side functional reanastomosis, distal closure), segment isolation for neobladder or continent pouch construction, and selected steps of catheterizable-channel construction. Other described uses are renal vessel transection in donor nephrectomy and bowel resection with reanastomosis during pelvic exenteration or complex revision surgery with adhesiolysis. Vessel transection requires a device and reload labeled for that vessel or tissue application. Reservoir construction with staples exposed to urine presents a separate long-term question from using staples to restore intestinal continuity.
See Staplers in Urologic Surgery for vascular safety, urinary staple exposure and the stapled-versus-hand-sewn neobladder evidence. Robotic stapling is not a routine requirement for a sacrocolpopexy or fistula repair merely because the operation is robotic.
Evidence Relevant to Counseling and Planning
| Study | What it found | What it cannot establish |
|---|---|---|
| Perkins 2018, donor nephrectomy | Initial 10-donor, single-surgeon series with one 45 mm white vascular load per case; warm ischemia under six minutes and blood loss 13 to 100 mL. The institution's device cost was $705 (robotic) versus $494 (laparoscopic) | No comparative control group; cannot establish equivalent ischemia time or graft outcomes. Historical local device prices are not current costs.[3] |
| Saxena 2025, RARC/diversion | 170-patient single-center cohort (76% ileal conduit, 21% neobladder, 2% continent pouch); ileus (no flatus or stool after day 4) 7.0%, small-bowel obstruction 4.7% and no intraoperative bowel injuries | Uncontrolled technique experience, not proof that the stapler reduced these complications.[4] |
| Holzmacher 2017, colorectal surgery | Retrospective comparison of 35 robotic versus 58 laparoscopic stapler cases; mean firings 1.86 versus 2.69 (P = .001) and cost per patient $473 versus $631 in the robotic group; operative time, blood loss and complication rate did not differ; leaks 1 versus 6 (P = .705) | Small single-institution retrospective comparison of the 45 mm EndoWrist stapler; nonsignificant leak differences do not demonstrate equivalence or predict urinary reconstruction outcomes.[5] |
| Atasoy 2018, rectal transection | Consecutive comparison of 107 cases; two leaks in each group | Different device configurations and limited event counts; not a randomized demonstration of equal safety.[6] |
Broader bariatric results also require caution. Coker's database study compared different time periods, so changes in selection, training and perioperative care accompanied any change in stapling technology.[7] Choksi's 2025 retrospective study associated some firing-angle measures with obstruction, but did not establish a universal prefire pause or find a relationship between its compression measures and bleeding.[8] The Chi 2025 publication is a study protocol, not comparative outcome evidence.[9]
Safe Setup, Firing and Recovery
FDA labeling guidance emphasizes compatibility, tissue suitability and a plan for device failure.[10]
- Confirm the correct system, instrument, reload, expiry and remaining firing allowance. Check current device corrections and recalls.
- Select by the labeled compressed tissue thickness and intended use, not by color alone. Color codes and open/closed staple heights are not interchangeable across product families.
- Obtain adequate exposure. Keep the intended tissue within the jaws and exclude adjacent vessels, bowel, clips and other obstructions. Avoid excess tension or forced clamping of unsuitable tissue.
- Follow the model's compression, firing and release instructions. Do not turn a time or angle reported in a different operation into a universal protocol.
- Confirm articulation is seated before firing, since firing at an extreme wrist angle across thick tissue can leave gaps in the staple line. Plan the cartridge sequence for long staple lines, such as reservoir construction, because cartridge exchange at the docked robot is slower than at the assistant port.
- Inspect for complete tissue division, staple formation and hemostasis; assess anastomotic integrity as appropriate to the procedure. Retain an immediate strategy for vascular control or repair if firing is incomplete or the device jams.
A robotic stapler can change who controls the firing step. Safe results still depend on tissue selection, exposure, inspection and the team's ability to respond to failure.
See also: Bowel Anastomosis, Needle Drivers, Vessel Sealers.
References
1. US FDA. Surgical Stapler Reload Recall: Intuitive Surgical Removes 8mm SureForm 30 Gray Reloads. May 5, 2026. Safety notice.
2. Intuitive. Da Vinci Stapling. Current US product specifications and FAQs, accessed September 12, 2026. Manufacturer information.
3. Perkins SQ, Giffen ZC, Buck BJ, et al. "Initial experience with the use of a robotic stapler for robot-assisted donor nephrectomy." J Endourol. 2018;32(11):1054–7. doi:10.1089/end.2018.0461
4. 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
5. Holzmacher JL, Luka S, Aziz M, et al. "The use of robotic and laparoscopic surgical stapling devices during minimally invasive colon and rectal surgery: a comparison." J Laparoendosc Adv Surg Tech A. 2017;27(2):151–5. doi:10.1089/lap.2016.0409
6. Atasoy D, Aytac E, Ozben V, et al. "Robotic versus laparoscopic stapler use for rectal transection in robotic surgery for cancer." J Laparoendosc Adv Surg Tech A. 2018;28(5):501–5. doi:10.1089/lap.2017.0545
7. Coker A, Sebastian R, Tatum J, et al. "Do advances in technology translate to improved outcomes? Comparing robotic bariatric surgery outcomes over two-time intervals utilizing the MBSAQIP database." Surg Endosc. 2023;37(10):7970–9. doi:10.1007/s00464-023-10208-5
8. Choksi S, Hirachan B, Ballo M, et al. "Characterizing advanced stapling technique using objective performance indicators in robotic-assisted sleeve gastrectomy: a retrospective cohort study." Surg Endosc. 2025;39(8):4848–56. doi:10.1007/s00464-025-11862-7
9. Chi YT, Hamm NC, Lee SH, et al. "A study protocol for a multi-specialty observational cohort comparing robotic stapler and bedside stapler outcomes in robotic-assisted surgeries." PLoS One. 2025;20(12):e0339191. doi:10.1371/journal.pone.0339191
10. US FDA. Surgical Staplers and Staples for Internal Use — Labeling Recommendations. October 8, 2021. Guidance.