Tri-Tome pc G22556Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002225565), received between May 27, 2016 and May 18, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (4 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.

• MalfunctionMay 18, 2018Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE WIRE GUIDE WAS PLACED INTO BILE DUCT SUCCESSFULLY AND CALCULUS WAS DETECTED THROUGH RADIOGRAPHY. THE USER [TRIED TO] USE TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME TO CUT THE DUODENAL PAPILLARY AND FOUND OUT THE PROXIMAL CUTTING WIRE TWISTED [INCORRECT CUTTING WIRE ORIENTATION]. THE USER FEELS THE HANDLE IS VERY STIFF TO PULL THE CUTTING WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7525991 ↗
• MalfunctionJul 10, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED FOUR (4) COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOMES. THE ISSUE IS WITH FOUR (4) UNITS OF TRI-30 FROM LOT W3851875. WHEN YOU SLIGHTLY BEND THE SPHINCTEROTOME, IT DOES NOT BEND STRAIGHT, BUT GOES VERY MUCH TO THE RIGHT. IT IS TOTALLY IMPOSSIBLE TO GET INTO THE PAPILLA [INCORRECT CUTTING WIRE ORIENTATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6697712 ↗
• MalfunctionJun 2, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TWO (2) COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOMES. THE CUTTING WIRE WAS NOT PROPERLY ALIGNED WITH THE CATHETER AND THEREFORE WHEN HE [THE PHYSICIAN] WANTS TO CUT, THE CUTTING [WIRE] IS NOT STRAIGHT AND GOES IN AN INCORRECT DIRECTION [INCORRECT CUTTING WIRE ORIENTATION]. [BOTH DEVICES WERE USED ON THE] SAME PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6608591 ↗
• MalfunctionMay 27, 2016Failure to Align; Failure to Align

  PER COMPLAINT EMAIL: "PHYSICIANS REPORT THAT THE DISTAL TIP DOESN'T HAVE THE ORIENTATION THAT THEY NEEDED." THIS WAS INITIALLY REPORTED TO BE PRIOR TO USE. ON 05/04/2016, WE RECEIVED THE FOLLOWING INFORMATION: THE MISORIENTATION WAS NOTED BEFORE AND AFTER INSERTING THE SPHINCTEROTOME INTO THE ENDOSCOPE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5684872 ↗