Tri-Tome pcRecalls & reported problems across all models

We found 8 models of Tri-Tome pc by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 141 adverse event reports in the FDA's MAUDE database, received between Feb 15, 2016 and Sep 1, 2026 — classified as 1 injury, 140 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (110 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Tri-Tome pc problems

Tri-Tome pc models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Tri-Tome pc G22555

  Unit, electrosurgical, endoscopic (with or without accessories)
  44 reports
• Tri-Tome pc G49197

  Unit, electrosurgical, endoscopic (with or without accessories)
  39 reports
• Tri-Tome pc G22554

  Unit, electrosurgical, endoscopic (with or without accessories)
  27 reports
• Tri-Tome pc G22583

  Unit, electrosurgical, endoscopic (with or without accessories)
  12 reports
• Tri-Tome pc G22584

  Unit, electrosurgical, endoscopic (with or without accessories)
  12 reports
• Tri-Tome pc G22556

  Unit, electrosurgical, endoscopic (with or without accessories)
  4 reports
• Tri-Tome pc G22557

  Unit, electrosurgical, endoscopic (with or without accessories)
  2 reports
• Tri-Tome pc G26826

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 report

Recent Tri-Tome pc adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Sharp Edges

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50542614 ↗
• MalfunctionMar 9, 2026Accessory Incompatible; Physical Resistance/Sticking

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK TRI-TOME PC PROTECTOR. IT WAS REPORTED THAT DURING THE CANNULATION PROCESS OF ERCP, THE WIRE GUIDE AND SPHINCTEROTOME DEVICE WERE EXCHANGED FOR THE NEXT PROCEDURE STEP. DURING THE WIRE GUIDE RETRACTION, IT WAS FOUND THAT THE WIRE GUIDE COATING PEELS OFF AT WIRE GUIDE PORT OF SPHINCTEROTOME DEVICE. AFTER THREE CONSECUTIVE WIRE GUIDES ENCOUNTERED THE SAME ISSUE, THE SPHINCTEROTOME DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. IMAGES OF THE DEVICE LABEL AND OF THE DEVICE SHOWING THE DAMAGED PORT WERE PROVIDED. 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 24547454 ↗
• MalfunctionFeb 4, 2026Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK TRI-TOME PC PROTECTOR. IT WAS REPORTED THAT THE ASSISTANT NURSE MAINTAINED THE GUIDE WIRE IN THE BILE DUCT AND PULLED THE HANDLE SLIGHTLY ON THE DEVICE, THE ENDOSCOPIC SCREEN CONFIRMED THAT THE KNIFE [CUTTING WIRE] WAS SEPARATED FROM THE TIP OF THE CATHETER AND REMOVED THE CATHETER FROM THE ENDOSCOPIC ACCESSORY CHANNEL AND USED A NEW PRODUCT. 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 24260096 ↗
• MalfunctionJan 26, 2026Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED TWO (2) COOK TRI-TOME PC SPHINCTEROTOMES. IT WAS REPORTED THAT THE USER ADVANCED THE DEVICE THROUGH ENDOSCOPE WORKING CHANNEL TO THE DUODENAL PAPILLA AND CONDUCTED CANNULATION, THE WIRE GUIDE WAS ADVANCED INTO THE PANCREAS DUCT AND CONNECTED WITH THE TRI DEVICE TO PRE-CUT BUT FOUND THE CUTTING WIRE WAS BROKEN. USER RETRACTED THE DEVICE AND CHANGED TO ANOTHER OF THE SAME DEVICE TO CONTINUE THE PROCEDURE, BUT THE BROKEN CUTTING WIRE OCCURRED AGAIN. USER CHANGED TO ANOTHER DOMESTIC BRAND DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ON 31DEC2025 WE RECEIVED THE DEVICES FOR EVALUATION, BOTH OF THE DEVICES APPEAR TO BE MISSING A PORTION OF THE BROKEN CUTTING WIRE AND WAS NOT RETURNED WITH THE DEVICES. THIS CHANGES THE INITIAL REPORTING DECISION FROM NOT REPORTABLE TO REPORTABLE. 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 24177077 ↗
• MalfunctionJan 14, 2026Material Separation

  DURING AN UNSPECIFIED ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK TRI-TOME PC PROTECTOR. IT WAS REPORTED THAT DURING USE, THE ELECTROSURGICAL KNIFE BLADE FRACTURED DURING INCISION OF THE PAPILLA, RESULTING IN A BLADE FRAGMENT REMAINING IN THE PATIENT. THE FRAGMENT WAS SUBSEQUENTLY RETRIEVED. THE PHYSICIAN QUESTIONED THE QUALITY OF THE DEVICE, AND A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE BLADE FRAGMENT WAS REMOVED FROM 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: Foreign Body In Patient

  MAUDE report 24068760 ↗
• MalfunctionOct 20, 2025Material Separation; Material Separation

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK TRI-TOME PC SPHINCTEROTOME. IT WAS INITIALLY REPORTED THAT DURING PREPARATION OF THE MATERIAL FOR USE IN AN ENDOSCOPIC PROCEDURE, IT WAS DISCOVERED THAT THE DEVICE CUTTING EDGE WAS LOOSE, MAKING IT IMPOSSIBLE TO USE SAFELY AND EFFECTIVELY. THEREFORE, THE MATERIAL WAS IMMEDIATELY DISCARDED AND REPLACED WITH A SPARE DEVICE, WITHOUT COMPROMISING THE PROCEDURE. PER ANSWERS TO ADDITIONAL QUESTIONS RECEIVED ON 24 SEP 2025, THE CUTTING WIRE ANCHOR DISCONNECTED AT THE PATIENT END OF DEVICE. [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 23338056 ↗
• MalfunctionJun 20, 2025Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK TRI-TOME PC SPHINCTEROTOME. IT WAS REPORTED THAT THE PHYSICIAN OPENED THE PACKAGE, THEN ADVANCED THE DEVICE THROUGH WIRE GUIDE INTO ENDOSCOPE WORKING CHANNEL CONDUCTED CANNULATION AND CHARGED THE POWER AND FOUND THAT THE CUTTING WIRE BROKE. THE PHYSICIAN CHANGED TO A NEW ONE TO USE. IMAGE OF THE DEVICE SHOWING THE CUTTING WIRE ANCHOR DETACHED WAS PROVIDED. [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 22300878 ↗
• 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 ↗
• MalfunctionFeb 11, 2025Material 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 THE NURSE STATED THAT THE DOCTOR INTRODUCED THE SPHINCTEROTOME, BUT WHEN MANIPULATING ITS CURVATURE, THE CUTTING WIRE CAME LOOSE, MAKING IT NECESSARY TO USE ANOTHER SPHINCTEROTOME AND THE PROCEDURE COULD BE CONTINUED NORMALLY. IMAGES OF THE DEVICE WERE PROVIDED SHOWING THE CUTTING WIRE ANCHOR DETACHED. [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 21354938 ↗
• 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 ↗
• MalfunctionApr 21, 2023Break

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE TRI-TOME SPHINCTEROTOME WAS BEING USED TO PERFORM A SPHINCTEROTOMY (ELECTROCAUTERY) WHEN THE CUTTING WIRE SNAPPED FROM THE DEVICE. DEVICE WAS IMMEDIATELY REMOVED FROM PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16785373 ↗
• 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 ↗

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