Tri-Tome pc G22555Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00827002225558), received between Feb 22, 2016 and Jun 4, 2025 — classified as 44 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (36 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 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2025Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. IT WAS INITIALLY REPORTED THAT THE DEVICE WAS TIGHTENED AND THE CUTTING WIRE BROKE/TORN. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED ON 9 MAY 2025. OUR EVALUATION OF THE RETURNED DEVICE ON 14 MAY 2025 DETERMINED THAT THE CUTTING WIRE SECURING COMPONENT (ANCHOR) HAS SEPARATED FROM THE CATHETER WITH DETACHMENT OF THE LONGER ANCHOR SEGMENT. HOWEVER, THE DETACHED SEGMENT WAS RETAINED WITHIN THE CATHETER AND ALL PORTIONS WERE INCLUDED IN THE RETURN. [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 Clinical Signs, Symptoms or Conditions

  MAUDE report 22142072 ↗
• MalfunctionMay 8, 2025Material Separation; Material Separation

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. IT WAS INITIALLY REPORTED THAT THE PHYSICIAN DETECTED THAT THE DEVICE WAS BROKEN AND IMMEDIATELY CHANGED TO A NEW ONE TO USE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. OUR EVALUATION OF THE RETURNED DEVICE ON 15 APR 2025 DETERMINED THAT THE ANCHOR HAS SEPARATED FROM THE TIP. [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 Clinical Signs, Symptoms or Conditions

  MAUDE report 21988145 ↗
• MalfunctionMar 20, 2025Material Separation; Material Separation

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. IT WAS REPORTED THAT THE USER OPENED THE PACKAGE AND FOUND THE CUTTING WIRE TIP BROKEN. USER CHANGED TO ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. THIS WAS INTERPRETED AS CUTTING WIRE BROKE IN ONE LOCATION WITHOUT DETACHMENT AND THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. PER OUR EVALUATION OF THE PRODUCT RETURNED ON 24 MAR 2025, THE CUTTING WIRE ANCHOR HAS SEPARATED FROM THE TIP OF THE CATHETER. [SUBJECT OF REPORT]. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21654374 ↗
• MalfunctionDec 12, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED THREE (3) TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOMES. THE ALIGNMENT OF THE TIP WAS BENT OUT OF SHAPE. 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 9460722 ↗
• MalfunctionAug 12, 2019Use of Device Problem; Failure to Cut; Use of Device Problem; Failure to Cut

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. THE CUTTING WIRE WAS BROKEN DURING THE ERCP PROCEDURE. THE USER CHANGED TO ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ON (B)(6) 2019, ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT THE DEVICE ALLOWED COAGULATION/BURNING BUT DID NOT CUT PROPERLY. 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 8885321 ↗
• MalfunctionJul 11, 2019Failure to Align; Failure to Align

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. THE CUTTING WIRE IS TWISTED. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8782408 ↗
• MalfunctionMay 7, 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 OPENED THE PACKAGE AND FLUSHED THE DEVICE WITH SUFFICIENT LUBRICATION. THE USER CONCERNS [CHECKED] THE ORIENTATION OF THE CUTTING WIRE AND FOUND OUT THE CUTTING WIRE ORIENTATION WAS POINTING AT 2 O'CLOCK INSIDE THE ENDOSCOPE [INCORRECT CUTTING WIRE ORIENTATION]. THE USER CANNOT ADJUST THE ORIENTATION AND RETRACTED THE DEVICE FROM THE ENDOSCOPE. THE USER CHANGED TO ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. 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 8588199 ↗
• MalfunctionApr 2, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. WHEN PERFORMING THE USE [SPHINCTEROTOMY], A DEFECT WAS NOTED IN THE TIP THAT DOES NOT ALLOW CANNULATION OF THE PAPILLA IN THE PATIENT. THE TIP WAS NOTED TO GO TO ONE (1) SIDE AND NOT UPWARDS [INCORRECT CUTTING WIRE ORIENTATION] AS IS THE MECHANISM OF ACTION. FOR THIS REASON, ANOTHER PAPILLOTOME WAS OPENED WITH WHICH THE PROCEDURE WAS PERFORMED. OUR ATTEMPTS TO COLLECT SPECIFIC PATIENT OUTCOME INFORMATION WERE UNSUCCESSFUL. BECAUSE THE COMPLAINANT STATED THAT THERE WAS NO ADVERSE EFFECTS TO THE PATIENT, WE CAN CONCLUDE THAT THIS INFORMATION DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8474967 ↗
• MalfunctionJun 29, 2018Material Separation; Material Separation

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOKTRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. WHEN THE NURSE OPENED THE PACKAGE, IT WAS FOUND THAT A SECTION OF CUTTING WIRE FELL OFF [CUTTING WIRE SECURING COMPONENT SEPARATED]. THE PROCEDURE WAS FINISHED BY CHANGING TO ANOTHER DEVICE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7652534 ↗
• MalfunctionNov 13, 2017Failure to Align; Failure to Align

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. AS REPORTED TO CUSTOMER RELATIONS: "THE SPHINCTEROTOME WAS TWISTED IMMEDIATELY AFTER BEING EXPOSED [INCORRECT CUTTING WIRE ORIENTATION]."

  Patient problems: No Patient Involvement

  MAUDE report 7026313 ↗
• MalfunctionNov 13, 2017Failure to Align; Failure to Align

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. AS REPORTED TO CUSTOMER RELATIONS: "THE SPHINCTEROTOME WAS TWISTED IMMEDIATELY AFTER BEING EXPOSED [INCORRECT CUTTING WIRE ORIENTATION]."

  Patient problems: No Patient Involvement

  MAUDE report 7026304 ↗
• MalfunctionOct 9, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. AS REPORTED TO CUSTOMER RELATIONS: WHEN USING A TRI-25M ON (B)(6) 2017, THE DOCTOR NOTICED THAT THE OUTPUT OF THE CUTTING WIRE WAS LATERALIZED [MALFUNCTION UNKNOWN FOLLOWING ANALYSIS OF PICTURE PROVIDED BY USER], THUS MAKING THE PAPILLOTOMY DIFFICULT AND MAKING IT IMPOSSIBLE TO USE. THE FOLLOWING CLARIFICATION WAS RECEIVED ON (B)(6) 2017 - THE PHYSICIAN NOTICED THAT THE TIP OF THE SPHINCTEROTOMY WAS TURNED TO AN UNUSUAL POSITION, MAKING THE CANNULATION HARDER [INCORRECT CUTTING WIRE ORIENTATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6928992 ↗
• MalfunctionSep 15, 2017Failure to Align; Failure to Align

  DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE PHYSICIAN USED A TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. THE TIP OF THE SPHINCTEROTOME IS TWISTED [INCORRECT CUTTING WIRE ORIENTATION]. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 9/1/17: THE ORIENTATION OF SPHINCTEROTOME DID NOT LET THE DOCTOR DO THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6867941 ↗
• MalfunctionJun 9, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. THE USER TRIED TO DO AN ERCP. THE PHYSICIAN, STATED THE SPHINCTEROTOME HAD VERY BAD ORIENTATION AND COULD NOT BE USED, VERY TWISTED. THE PATIENT HAD A VERY DISTORTED ANATOMY. ANOTHER DEVICE WAS USED WITH NO PROBLEMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6629921 ↗
• MalfunctionJun 2, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. THE ORIENTATION POINTED TO THE 9 O'CLOCK [POSITION], REAL WRONG ORIENTATION [INCORRECT CUTTING WIRE ORIENTATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6608821 ↗
• MalfunctionMar 20, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TWO (2) COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOMES. AFTER INTRODUCING THE PRODUCT INTO THE ENDSOSCOPE, IT CAME OUT WRONG [INCORRECT CUTTING WIRE ORIENTATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6417848 ↗
• MalfunctionMar 20, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TWO COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOMES. AFTER INTRODUCING THE PRODUCT INTO THE ENDOSCOPE, IT CAME OUT WRONG [INCORRECT CUTTING WIRE ORIENTATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6417845 ↗
• MalfunctionMar 16, 2017Failure to Align; Failure to Align

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6411352 ↗
• MalfunctionMar 16, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. THERE WAS ORIENTATION PROBLEM. THE ORIENTATION WAS NOT CORRECT [INCORRECT CUTTING WIRE ORIENTATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6410783 ↗
• MalfunctionJan 10, 2017Break; Break

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. AS REPORTED TO CUSTOMER RELATIONS: DURING THE PAPILLOTOMY, THE PAPILLOTOME'S CUTTING WIRE RUPTURED [CUTTING WIRE BROKE IN TWO LOCATIONS], MAKING IT IMPOSSIBLE TO USE. IT WAS NECESSARY TO USE THE PRE-CUT PAPILLOTOME [NEEDLE KNIFE]. THE FOLLOWING CLARIFICATION WAS RECEIVED 1/06/2017 FROM THE DISTRIBUTOR: "[IN] THE MEDICAL REPORT WE RECEIVED ON THIS CASE, THERE WAS NO INFORMATION FROM WHICH PART OF THE DEVICE WAS INSIDE THE PATIENT OR EVEN THAT AN ADDITIONAL PROCEDURE WAS REQUIRED. WE SOON CONCLUDED THAT THERE WAS NO HARM TO THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6236853 ↗
• MalfunctionNov 11, 2016Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. ONCE INTRODUCED INTO THE ENDOSCOPE, THE SPHINCTEROTOME ORIENTATION WAS TO THE LEFT [INCORRECT CUTTING WIRE ORIENTATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6096796 ↗
• MalfunctionNov 11, 2016Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TWO (2) COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOMES. ONCE INTRODUCED INTO THE ENDOSCOPE, BOTH OF THE SPHINCTEROTOMES' ORIENTATION WAS TO THE LEFT [INCORRECT CUTTING WIRE ORIENTATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6096795 ↗
• MalfunctionOct 14, 2016Break; Break

  THIS CORRECTION FOLLOW UP REPORT IS BEING SENT TO CANCEL THE INITIAL REPORT SUBMITTED RELATING TO THIS EVENT. PLEASE REFERENCE THE ADDITIONAL MANUFACTURER NARRATIVE NOTES SECTION FOR THIS JUSTIFICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6029595 ↗
• MalfunctionAug 26, 2016Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. AS REPORTED TO CUSTOMER RELATIONS: "WHEN TRYING TO MAKE CANNULATION, THE TIP OF THE SPHINCTEROTOME IS CROOKED, YOU CAN NOT MAKE THE CUT." [INCORRECT CUTTING WIRE ORIENTATION/TIP POINTED WRONG DIRECTION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5906234 ↗
• MalfunctionAug 9, 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 CAME OUT [OF THE ENDOSCOPE] WITH BAD ORIENTATION. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5856970 ↗