Tri-Staple 2.0 SIGCIR31MTRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521703742), received between Mar 5, 2026 and Sep 22, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Device Slipped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860283 ↗
• MalfunctionMar 13, 2026Failure to Cut; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ROBOTIC LOW ANTERIOR RESECTION, WHILE CREATING THE ANASTOMOSIS, THE STAPLER FIRED BUT DID NOT COMPLETE THE CUT, LEAVING THE TISSUE PARTIALLY CUT. ADDITIONALLY, THE SCREEN SHOWED A YELLOW EXCLAMATION MARK ABOVE THE RELOAD SWIM LANE THE SURGEON HAD TO OPEN THE ANASTOMOSIS AND RELEASE THE ANVIL FROM THE STAPLED TISSUE, THEN RESECT THE ANASTOMOSIS AND RECREATE ANOTHER ANASTOMOSIS USING ANOTHER RELOAD WITH THE SAME HANDLE. THE PROCEDURE WAS EXTENDED BY 1 HOUR AND 30 MINUTES.

  Patient problems: Failure to Anastomose; Insufficient Information; Tissue Breakdown

  MAUDE report 24599148 ↗
• MalfunctionMar 10, 2026Device Displays Incorrect Message; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC SIGMOIDECTOMY, AFTER THE POWERED CIRCULAR STAPLER COMPLETED ITS STAPLING AND FOLLOWING FIRING SEQUENCE AND BEFORE TAPPING UP ON THE TOGGLE, YELLOW SWIM LANES TWO FOR ADAPTER AND THREE FOR RELOAD TURNED YELLOW WITH A WARNING TRIANGLE. THE STAPLER PROMPTED THE SURGEON TO OPEN THE SPIKE, AND NOTHING HAPPENED, BUT THE SPIKE WAS FULLY EXTENDED. THE SURGEON EXTENDED THE SPIKE AND THE MIDDLE YELLOW SWIMLANE TURNED GREEN BUT THE LAST YELLOW SWIM LANE REMAINED YELLOW. THE SURGEON PROCEEDED TO PULL THE STAPLER OUT, AND IT CAME OUT WITHOUT THE ANVIL CONNECTED TO THE SPIKE. THE SURGEON HAD TO MANUALLY PULL THE ANVIL FROM THE PATIENT'S RECTUM. UPON INSPECTION, DONUTS WERE COMPLETE, AND THE LEAK TEST WAS NEGATIVE. THE SURGICAL TIME WAS EXTENDED BY 25 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557888 ↗
• MalfunctionMar 5, 2026Failure to Cut; Device Displays Incorrect Message; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC SIGMOID COLON PROCEDURE, THE DEVICE WAS APPEARING TO FIRE BUT DID NOT CUT, A YELLOW INDICATOR FOR BOTH THE ADAPTER AND RELOAD WAS SHOWN. THE DEVICE ATTEMPTED TO OPEN OR ADVANCE THE TILT TOP ANVIL BUT DID NOT, AND THE SCREEN REMAINED YELLOW ON THE RELOAD LANE DURING THE SIGMOID CIRCULAR STAPLING STEP. THE SURGICAL TIME WAS EXTENDED BY APPROXIMATELY 45 MINUTES. A NEW ANASTOMOSIS WAS CREATED AND A MANUAL CIRCULAR STAPLER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 24520948 ↗