Tri-Staple 2.0 SIGC60VTRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521543522), received between Feb 26, 2018 and Dec 1, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROUX EN Y, WHILE PERFORMING A SMALL BOWEL ANASTOMOSIS, THE DEVICE ENTERED FIRING MODE BUT DID NOT FIRE ON FIVE CARTRIDGE'S. ON THE LAST SIXTY MILLIMETER LOADING UNIT, THE SURGEON WAS NOT ABLE TO SQUEEZED THE HANDLE AFTER PRESSING THE GREEN BUTTON. TO RESOLVE THE ISSUE, THE SURGEON USED A COMPETITOR'S DEVICE. THE SURGERY GOT EXTENDED FOR THIRTY MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12913824 ↗
• InjuryDec 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVE A GASTRIC BYPASS PROCEDURE, THERE WAS STAPLE LINE BLEEDING. PATIENT LOST A TOTAL OF 1,750CC OF BLOOD THAT REQUIRED BLOOD TRANSFUSION. DUE TO THE POST-OPERATIVE EVENT, THE PATIENT HAD EXTENDED HOSPITALIZATION OF 3 DAYS.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 9530225 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE A GASTRIC BYPASS PROCEDURE, STAPLE LINES LOOKED FINE. BLEEDING OCCURRED HOURS FOLLOWING SURGERY AFTER POST OPERATIVE ANTICOAGULANT. PATIENT HAD 1250CC BLOOD LOSS AND HAD 3 DAYS INCREASED HOSPITAL STAY.

  Patient problems: Blood Loss

  MAUDE report 9519693 ↗
• MalfunctionFeb 26, 2018Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ROUX-EN-Y, THE DEVICE CAUSED TISSUE DAMAGE WHILE STAPLING THE JEJUNOJEJUNOSTOMY ANASTOMOSIS. AFTER FIRING THE RELOAD AND PULLED BACK ON THE KNIFE BLADE, THERE WAS A SMALL PIECE OF TISSUE THAT TEARED AND PULLED BACK WITH THE KNIFE BLADE. THIS DID NOT HAPPENED ON SINGLE USE LOADING UNIT. NO INTERVENTION WAS NEEDED TO COMPLETE THE CASE.

  Patient problems: Tissue Damage

  MAUDE report 7297612 ↗