Tri-Tome pc G22557Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002225572), received between Feb 29, 2016 and Dec 5, 2016 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (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.

• MalfunctionDec 5, 2016Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. DURING A BILIO-PANCREATIC ENDOSCOPIC CATHETERIZATION, THE SPHINCTEROTOME THAT WAS BEING USED WAS BENT AND NON-FUNCTIONAL [TIP BENT/INCORRECT CUTTING WIRE ORIENTATION]. THE INTEGRITY OF THE DEVICE HAD NOT BEEN VERIFIED BEFORE USE. THE PHYSICIAN TOOK OUT THE SPHINCTEROTOME, AND INTRODUCED IT AGAIN. IT WAS "COMPLETELY TWISTED". ANOTHER DEVICE WAS USED WITHOUT FURTHER PROBLEMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6144482 ↗
• MalfunctionFeb 29, 2016Positioning Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TWO (2) COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOMES. WHEN THE SPHINCTEROTOME PASSES [EXITS] THE DUODENOSCOPE, IT'S ORIENTATION GOES TO 10 OR 2 [O'CLOCK], BUT NEVER TO 12 [O'CLOCK] [INCORRECT CUTTING WIRE ORIENTATION]. THIS DOES NOT PERMIT TO REALIZE [COMPLETE] THE PROCEDURE.

  Patient problems: No Information

  MAUDE report 5468102 ↗