Tri-Staple 2.0 SIGCIR31XTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521703759), received between Jan 30, 2026 and Apr 17, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Difficult to Remove; Failure to Cut; Device Displays Incorrect Message; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC SIGMOID COLECTOMY TO CREATE AN ANASTOMOSIS IN THE DISTAL COLON, WHEN CLOSING THE ANVIL, THE EXCESSIVE FORCE ICON APPEARED. IT WAS NOTED THAT THE ICON WAS INTENTIONAL, TO WAIT SEVERAL SECONDS FOR ANVIL TO CONTINUE TO CLOSE AND REACH 100% CLOSED. ONCE THE FIRING BUTTON ILLUMINATED, THE PHYSICIAN PROCEEDED TO FIRE AS USUAL. THE STAPLE ICON ILLUMINATED AS USUAL, AND THE KNIFE CUTTING GRAPHIC ILLUMINATED AS USUAL, BUT THEN SHOWED A SPIKE ERROR GRAPHIC FOR 1 SECOND WHICH WAS A RED CIRCLE WITH LINE THAT APPEARED ON THE KNIFE BLADE. THE NORMAL ICON APPEARED INSTRUCTING USER TO PRESS UP BUTTON TO OPEN ANVIL. AS PHYSICIAN WENT TO OPEN ANVIL, THE RELOAD YELLOW SWIM LANE ERROR APPEARED. THE ANVIL DID OPEN AS USUAL, BUT THE STAPLER WAS EXTREMELY DIFFICULT TO REMOVE FROM THE ANASTOMOSIS. THE PHYSICIAN NOTED IT FELT AS THOUGH THE STAPLER DID NOT CUT ALL THE WAY. AFTER 2-3 MINUTES, THE PHYSICIAN WAS ABLE TO WIGGLE THE STAPLER OUT OF THE ANASTOMOSIS AND PATIENT'S BODY, BUT UPON SCOPING, 1/4 OF THE ANASTOMOSIS LOOKED LOOSE. IT WAS NOTED THAT THE PROCEDURE WAS EXTENDED BY 10 MINUTES. THE SURGEON SUTURED OVER THE ANASTOMOSIS AND PROCEEDED WITH THE CAS

  Patient problems: Failure to Anastomose

  MAUDE report 24915757 ↗
• InjuryJan 30, 2026Misfire; Failure to Form Staple

  IT WAS REPORTED THAT AFTER FIRING THE POWERED CIRCULAR STAPLER, A SIZEABLE HOLE WAS OBSERVED IN THE ANASTOMOSIS AND AN INCOMPLETE DISTAL DONUT WAS NOTED UPON INSPECTION. THE SURGEON REDID THE ANASTOMOSIS USING THE SAME EQUIPMENT, AND THE PROCEDURE WORKED AS INTENDED.

  Patient problems: Failure to Anastomose; No Clinical Signs, Symptoms or Conditions; Tissue Breakdown

  MAUDE report 24221198 ↗