Tri-Tome pc G22584Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00827002225848), received between Feb 15, 2016 and May 7, 2018 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (11 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2018Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. THE DEVICE [CUTTING WIRE] WAS IN THE WRONG ORIENTATION. IT WAS IN THE 1 O'CLOCK TO 2 O'CLOCK POSITION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7490707 ↗
• MalfunctionApr 16, 2018Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. THE DEVICE HAD BAD ORIENTATION [INCORRECT CUTTING WIRE ORIENTATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7432202 ↗
• MalfunctionJan 23, 2018Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. THE TIP OF THE SPHINCTEROTOME BENT IN THE OPPOSITE DIRECTION [INCORRECT CUTTING WIRE ORIENTATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7212070 ↗
• MalfunctionDec 21, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. THE SPHINCTEROTOME CURVED INCORRECTLY [INCORRECT CUTTING WIRE ORIENTATION]. THE PROCEDURE WAS COMPLETED BY USING ANOTHER OF THE SAME DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7138746 ↗
• MalfunctionDec 21, 2017Material Separation; Material Separation

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. THE CUTTING WIRE ON THE SPHINCTEROTOME TIP WAS NOTED TO BE BROKEN UPON OPENING PACKAGING; UNUSABLE FOR PROCEDURE. NO PATIENT CARE WAS IMPACTED. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 12/06/17 AND IT WAS OBSERVED THAT THE CUTTING WIRE SECURING COMPONENT SEPARATED FROM THE CATHETER.

  Patient problems: No Patient Involvement

  MAUDE report 7138731 ↗
• MalfunctionDec 21, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. THE TIP OF THE SPHINCTEROTOME BOWED BACKWARDS; ORIENTATION OFF [INCORRECT CUTTING WIRE ORIENTATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7138708 ↗
• MalfunctionMar 24, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. WHEN THE DOCTOR EXITS THE SPHINCTEROTOME FROM THE PACKAGE AND AFTER FROM OPERATOR CHANNEL, THE EXTREMITY DOESN'T HAVE THE GOOD ORIENTATION BUT "TWISTS" [INCORRECT CUTTING WIRE ORIENTATION]. ALL DOCTORS AT THIS HOSPITAL HAVE HAD THE SAME PROBLEM FOR SEVERAL MONTHS. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 3/8/17: "WE COULD SEE THE ORIENTATION PROBLEM OUTSIDE THE DUODENOSCOPE, WHEN NURSE OPENED THE PACKAGE!" SEE RELATED MDRS: 1037905-2017-00125, 1037905-2017-00127, 1037905-2017-00128.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6431846 ↗
• MalfunctionMar 24, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. WHEN THE DOCTOR EXITS THE SPHINCTEROTOME FROM THE PACKAGE AND AFTER FROM OPERATOR CHANNEL, THE EXTREMITY DOESN'T HAVE THE GOOD ORIENTATION BUT "TWISTS" [INCORRECT CUTTING WIRE ORIENTATION]. ALL DOCTORS AT THIS HOSPITAL HAVE HAD THE SAME PROBLEM FOR SEVERAL MONTHS. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 3/8/17: "WE COULD SEE THE ORIENTATION PROBLEM OUTSIDE THE DUODENOSCOPE, WHEN NURSE OPENED THE PACKAGE!" SEE RELATED MDRS: 1037905-2017-00126, 1037905-2017-00127, 1037905-2017-00128.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6431802 ↗
• MalfunctionMar 20, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. THE TIP CAME OUT CROOKED FROM THE ENDOSCOPE [INCORRECT CUTTING WIRE ORIENTATION]. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6417844 ↗
• MalfunctionSep 27, 2016Failure to Align; Failure to Align

  AS REPORTED TO CUSTOMER RELATIONS: "DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. AS THEY BOWED THE SPHINCTEROTOME, IT BOWED TO THE LEFT [INCORRECT CUTTING WIRE ORIENTATION]. IT WAS REMOVED AND THEY USED ANOTHER SPHINCTEROTOME WHICH HAD THE SAME RESULTS [SECOND DEVICE ALSO HAD INCORRECT CUTTING WIRE ORIENTATION] (SEE MDR REPORT NUMBER 1037905-2016-00380). THEY USED A DIFFERENT COOK SPHINCTEROTOME TO CONTINUE THE PROCEDURE WITH NO FURTHER COMPLICATIONS. THERE WAS NO HARM TO THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5980722 ↗
• MalfunctionSep 27, 2016Failure to Align; Failure to Align

  AS REPORTED TO CUSTOMER RELATIONS: "DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. AS THEY BOWED THE SPHINCTEROTOME, IT BOWED TO THE LEFT [INCORRECT CUTTING WIRE ORIENTATION] (SEE MDR REPORT NUMBER 1037905-2016-00379). IT WAS REMOVED AND THEY USED ANOTHER SPHINCTEROTOME WHICH HAD THE SAME RESULTS [SECOND DEVICE ALSO HAD INCORRECT CUTTING WIRE ORIENTATION]. THEY USED A DIFFERENT COOK SPHINCTEROTOME TO CONTINUE THE PROCEDURE WITH NO FURTHER COMPLICATIONS. THERE WAS NO HARM TO THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5980713 ↗
• MalfunctionFeb 15, 2016Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. THERE WAS VERY BAD ORIENTATION OF THE SPHINCTEROTOME (9 O'CLOCK) [INCORRECT CUTTING WIRE ORIENTATION]. IT [THE SPHINCTEROTOME CATHETER] WAS TWISTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5436116 ↗