Tri-Staple 2.0 SIG60AVMRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521808980), received between Jul 22, 2022 and Aug 24, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50420866 ↗
• MalfunctionAug 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a robotic laparoscopic left nephrectomy, there was a bleeding from the staple line was reported after firing the reload. The surgeon placed a weck clip at the bleeding site.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50420845 ↗
• MalfunctionMay 27, 2026Entrapment of Device

  IT WAS REPORTED THAT DURING A PROCEDURE, THE RELOAD WOULD NOT OPEN AFTER SUCCESSFUL FIRING. THE DEVICE WAS LOCKED ON THE TISSUE AND COULD NOT BE REMOVED. IT WAS FURTHER REPORTED THAT THE RELOAD WAS ABLE TO BE REMOVED SAFELY, AND NO INTERVENTION WAS DONE OR REQUIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25311096 ↗
• MalfunctionMar 31, 2026Entrapment of Device

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY, THE DEVICE LOCKED ON TISSUE AND COULD NOT BE REMOVED WHEN THE STAPLER WAS FIRED OVER THE APPENDIX FOR REMOVAL. THE STAPLER JAWS WERE GENTLY OPENED WITH A HEMOSTAT TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747384 ↗
• MalfunctionAug 22, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A SIDE-TO-SIDE ANASTOMOSIS DURING FUNCTIONAL END-TO-END ANASTOMOSIS DURING COLON RESECTION, THE FIRING ADVANCED FOR ABOUT ONE CM, AND THE SURGEON INTENTIONALLY STOPPED TO CHECK FOR ENTANGLEMENT. AN ATTEMPT WAS MADE TO RESUME FIRING, BUT FIRING COULD NOT BE PERFORMED. THE ASSISTANT PHYSICIAN REPORTED THAT SOME BUTTON WAS TOUCHED DURING THE CHECK AFTER FIRING WAS STOPPED. THE KNIFE WAS RETURNED, AND A NEW CARTRIDGE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20034539 ↗
• MalfunctionJun 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, OF A LAPAROSCOPIC GASTRIC BYPASS ON THE STOMACH AND INTESTINE, THE PATIENT HAD DIGESTIVE BLEEDING. THE ISSUE OCCURRED ON THREE RELOADS. THE PATIENT WAS PUT UNDER OBSERVATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19495322 ↗
• MalfunctionJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE A LAPAROSCOPIC GASTRIC BYPASS, THE PATIENT HAD DIGESTIVE BLEEDING FROM ALL THREE DEVICE. THE PATIENT WAS PLACED UNDER OBSERVATION.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 19479816 ↗
• MalfunctionJul 22, 2022Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC GASTRIC BYPASS, WHEN CREATING THE STOMACH POUCH, AND WITH THE SIDE TO SIDE ANASTOMOSIS, THE STAPLER FIRED BUT THE 2 RELOADS CANNOT BE REMOVED FROM THE 2 ADAPTERS AFTER BEING USED. TWO NEW ADAPTER SETS HAD TO BE OPENED AND RECONNECTED TO THE HANDLE. SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15089266 ↗