Tri-Tome pc G22583Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00827002225831), received between May 6, 2016 and Jul 27, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (8 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.

• MalfunctionJul 27, 2023Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. IT WAS REPORTED THAT AFTER STARTING ERCP, AND ENTERING THE DUODENAL PAPILLA WITH THE SPHINCTEROTOMY CANNULA, THE PROCESS OF OPENING THE PAPILLA WAS STARTED. THE CUTTING WIRE BREAKS, MAKING IT IMPOSSIBLE TO CUT THE DUODENAL PAPILLA. A NEW CANNULA WAS REQUIRED TO COMPLETE THE PROCEDURE. IMAGES OF THE DEVICE WERE PROVIDED THAT SHOW THE CUTTING WIRE ANCHOR DISCONNECTED FROM THE CATHETER AT THE PATIENT END OF DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17408276 ↗
• MalfunctionJun 29, 2021Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME AND STATED THAT AFTER INTRODUCING THE PRODUCT INSIDE THE PATIENT THE NURSE TRIED TO CURVE MORE OF THE CUTTING WIRE AND THE CUTTING WIRE CAME LOOSE FROM ONE END. THE CUTTING WIRE WAS BROKEN BEFORE USING OR CUTTING WITH THE UNIT. A PHOTO OF THE DEVICE WAS PROVIDED WHICH SHOWS THE CUTTING WIRE SECURING COMPONENT SEPARATED FROM CATHETER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12083250 ↗
• MalfunctionFeb 10, 2021Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. WHEN REMOVING THE PAPILLOTOME FROM THE WORKING CHANNEL, THE DOCTOR VERIFIED THAT THE CUTTING WIRE WAS BROKEN. IT WAS NECESSARY TO OPEN ANOTHER UNIT OF MATERIAL TO FINISH WITH THE PROCEDURE. A PHOTO WAS RECEIVED WITH THE COMPLAINT DEPICTING THE CUTTING WIRE SECURING COMPONENT SEPARATED FROM THE CATHETER, BUT DID NOT DETACH [SUBJECT OF REPORT]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11309600 ↗
• MalfunctionAug 5, 2019Failure to Align; Failure to Align

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. A SPHINCTEROTOME WAS USED BY THE PHYSICIAN AND TURNED OUT TO BE DEFECTIVE PRIOR TO USE. THE CUTTING WIRE WAS NOT STRAIGHT [TIP POINTING IN THE WRONG DIRECTION]. THEY HAD TO OPEN A NEW ONE TO FINISH THE PROCEDURE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8861734 ↗
• MalfunctionJul 19, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. THE DEVICE CAME OUT OF THE ENDOSCOPE COMPLETELY BACKWARDS [INCORRECT CUTTING WIRE ORIENTATION]. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED 25-JUN-2019: THE PRODUCT WAS INSERTED THROUGH AN OLYMPUS TJF-180 ENDOSCOPE. THE PRODUCT WAS NEVER CONNECTED TO CAUTERY AND ONLY MADE MINOR CONTACT WITH THE PATIENT SINCE ORIENTATION OF THE DEVICE WAS INADEQUATE TO CANNULATE SPHINCTER OF ODDI. THE PHYSICIAN OR STAFF DID NOT MANUALLY PRE-FORM THE TIP OF THE DEVICE PRIOR TO USE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8809033 ↗
• MalfunctionJun 17, 2019Failure to Align; Material Twisted/Bent; Failure to Align; Material Twisted/Bent

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. THIS DEVICE WAS CONSIDERED DEFECTIVE DUE TO THE MISPLACEMENT OF THE CUTTING WIRE ON THE TIP OF THE CATHETER. IT [CUTTING WIRE] WAS TILTED MORE TO THE RIGHT THEN IN THE MIDDLE [TIP BENT WRONG WAY], SO PERFORMING THE SPHINCTEROTOMY WOULD HAVE BEEN ALMOST IMPOSSIBLE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8705506 ↗
• MalfunctionJan 10, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. [THE USER] BY ARCHERING [BOWING] THE SPHINCTEROTOME, THE SAME CURVED AT NINE O'CLOCK [INCORRECT CUTTING WIRE ORIENTATION], [MAKING IT] IMPOSSIBLE FOR CATHETERIZATION OF THE BILIARY DUCT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8237664 ↗
• MalfunctionNov 14, 2018Failure to Align; Failure to Align

  DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. AS REPORTED TO CUSTOMER RELATIONS: "WHEN USING THE PAPILLOTOME, DURING THE PROCEDURE OF PAPILLOTOMY, THE DOCTOR REQUESTED THAT THE MOVEMENT TO ARCH BE PERFORMED AND THE MATERIAL PRESENTED DEFECT, ARCHING TO THE OPPOSITE SIDE [INCORRECT CUTTING WIRE ORIENTATION] NOT BEING POSSIBLE TO PERFORM THE PAPILLOTOMY." ADDITIONAL CLARIFICATION WAS RECEIVED ON 30-OCT-2018: IN THIS CASE, I THINK THE MOST APPROPRIATE FORM WOULD BE ¿ARC¿. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8072052 ↗
• MalfunctionJul 3, 2018Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TWO (2) COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOMES. AS REPORTED TO CUSTOMER RELATIONS: "AT THE TIME, WHILE TRYING TO CANNULATE, THE FIRST SPHINCTEROTOME HAD BAD ORIENTATION [INCORRECT CUTTING WIRE ORIENTATION]. THE ASISTANT THREW IT AWAY AND OPENED ANOTHER BRAND NEW SPHINCTEROTOME, WHICH HAD THE SAME PROBLEM [INCORRECT CUTTING WIRE ORIENTATION]. FINALLY, THE THIRD SPHINCTEROTOME WORKED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7660726 ↗
• MalfunctionJun 1, 2018Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. THE PHYSICIAN WAS USING [THE SPHINCTEROTOME] FOR THE FIRST TIME. DURING THE PROCEDURE, THE FILAMENT [CUTTING WIRE] ATTACHED TO THE DOME TIP BROKE AND REMOVED [SEPARATED] FROM THE DOME TIP. CLARIFICATION RECEIVED ON 05/08/2018. THE CUTTING WIRE ANCHOR SEPARATED FROM THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7560024 ↗
• MalfunctionMar 12, 2018Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. DURING ENDOSCOPIC RETROGRADE CHOLANGIOGRAPHY, A PAPILLOTOME WAS OPENED. SHORTLY AFTER THE PASSAGE OF THE SAME [DEVICE] THROUGH THE WORKING CHANNEL, IT WAS VERIFIED THAT THE GAUNTLET RESPONSIBLE FOR THE ARCH OF THE TIP OF THE PAPILLOTOME WAS STUCK [FAILURE TO BOW]. [THIS DID] NOT ALLOW THE PROPER PERFORMANCE OF THE PROCEDURE WITH THIS ACCESSORY. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE ADDITIONAL QUESTIONS RECEIVED ON (B)(6) 2018 INDICATE THAT MISORIENTATION WAS NOTED AFTER BOWING THE DISTAL END. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018: THE GAUNTLET [CUTTING WIRE] WAS NOT ABLE TO BEND THE TIP [UNABLE TO BOW]. THE CUTTING WIRE WAS ALSO NOT IN THE CORRECT POSITION [INCORRECT CUTTING WIRE ORIENTATION] (SUBJECT OF THIS REPORT). THE DISTAL END OF THE ATTACHMENT TO THE APPARATUS WAS THE USUAL. I DO NOT KNOW HOW TO PRECISE IN CM, HOWEVER, THE ENTIRE CUTTING WIRE AND AT LEAST ANOTHER 0.5 CM OF THE PLASTIC PORTION WAS EXPOSED, YET THE HANDLE WAS NOT ABLE TO BEND THE END OF THE ACCESSORY [UNABLE TO BOW]. THE DISORIENTATION WA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7330563 ↗
• MalfunctionMay 6, 2016Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. THE SPHINCTEROTOME WENT OUT OF THE ENDOSCOPE IN THE WRONG ORIENTATION, IT WAS NOT POSIBLE TO FACE THE PAPILLA AND DO THE SPHINCTEROTOMY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5636643 ↗