Tri-Tome pc G49197Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00827002491977), received between May 24, 2016 and Mar 9, 2026 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (26 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionNov 5, 2019Failure to Align; Failure to Align

  IN PREPARATION FOR A PROCEDURE, THE PHYSICIAN CHOSE A COOK TRI-TOME PC PROTECTOR. THE USER OPENED THE PACKAGE AND FOUND OUT THE CUTTING WIRE ORIENTATION WAS DEVIATED [POINTED IN THE WRONG DIRECTION]. IT WAS NOT USED ON PATIENT. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9280491 ↗
• MalfunctionOct 21, 2019Failure to Align; Failure to Align

  IN PREPARATION FOR A PROCEDURE, THE PHYSICIAN CHOSE A COOK TRI-TOME PC PROTECTOR SPHINCTEROTOME. THE USER OPENED THE PACKAGE AND FOUND OUT THE TIP OF CUTTING WIRE WAS DISTORTED. THE ENTIRE TIP APPEARED TO BE BENT OUTSIDE OF THE 11 O'CLOCK TO 1 O'CLOCK RANGE. THE STYLET WAS NOT REMOVED. IT WAS NOT USED ON PATIENT. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9216168 ↗
• MalfunctionOct 18, 2019Failure to Align; Failure to Align

  DURING A ENDOSCOPIC SPHINCTEROTOMY (EST), THE PHYSICIAN USED A COOK TRI-TOME PC PROTECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY TO COOK BY THE USER: THE DEVICE WAS ADVANCED THROUGH OLYMPUS'S ENDOSCOPE WHICH WAS PREVIOUSLY INSERTED TO THE DUODENUM THROUGH MOUTH TO PERFORM EST. HOWEVER, BECAUSE THE CUTTING WIRE WOULD NOT BE ORIENTED TOWARD THE BILE DUCT, EST COULD NOT BE PERFORMED. THEREFORE, ANOTHER MANUFACTURER'S EST KNIFE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. 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 9209889 ↗
• MalfunctionOct 16, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE , THE PHYSICIAN USED A COOK TRI-TOME PC PROTECTOR. IT WAS OBSERVED DURING CATHETERIZATION [CANNULATION] IN THE ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY PROCEDURE THAT THE PAPILLOTOME TRI-25M-P CUT-OFF WAS REVERSED [INCORRECT CUTTING WIRE ORIENTATION]. THE GUIDEWIRE WAS NOT IN POSITION BETWEEN 11AM. THE PAPILLOTOME WAS REPLACED BY ANOTHER DEVICE WITH THE CORRECT ORIENTATION. 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 9198743 ↗
• MalfunctionAug 16, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND ENDOSCOPIC SPHINCTEROTOMY (EST), THE PHYSICIAN USED A COOK TRI-TOME PC PROTECTOR SPHINCTEROTOME. FOR ERCP CANNULATION AND EST, THE PHYSICIAN INSERTED THE SPHINCTEROTOME INTO THE SCOPE WITH A COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDE (AWG2-35-450), AND TRIED TO ACCESS TO THE AMPULLA. THE DIRECTION OF THE TIP WAS NOT THE 11 O'CLOCK DIRECTION. THEY COULD NOT ACCESS TO THE AMPULLA AND USED A NEW SAME DEVICE FOR CANNULATION. 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 8903592 ↗
• MalfunctionAug 16, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND ENDOSCOPIC SPHINCTEROTOMY (EST), THE PHYSICIAN USED A COOK TRI-TOME PC PROTECTOR SPHINCTEROTOME. FOR ERCP CANNULATION AND EST, THE PHYSICIAN INSERTED THE SPHINCTEROTOME INTO THE ENDOSCOPE WITH A COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDE (AWG2-35-450), AND TRIED TO ACCESS THE AMPULLA. THE DIRECTION OF THE TIP WAS NOT THE 11 O'CLOCK DIRECTION. THEY COULD NOT ACCESS THE AMPULLA AND USED A NEW SAME DEVICE FOR CANNULATION. 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 8903590 ↗
• MalfunctionAug 8, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOKTRI-TOME PC PROTECTOR. THE USER DETECTED A CUTTING WIRE ORIENTATION ISSUE DURING THE ERCP 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 8876131 ↗
• MalfunctionJul 18, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC PROTECTOR (TRI-25M-P). IN CHARACTERIZING THE PAPILLA OF VATER WITH THE TRI-25M-P PAPILLOTOME [SIC], IT WAS FOUND THAT THE CUTTING WIRE WAS INVERTED [INCORRECT CUTTING WIRE ORIENTATION], HAVING TO BE REPLACED BY ANOTHER PAPILLOTOME. 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 8804372 ↗
• MalfunctionJul 15, 2019Use of Device Problem; Failure to Align; Use of Device Problem; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC PROTECTOR. WHEN THEY TRIED TO DO ENDOSCOPIC SPHINCTEROTOMY (EST), THE PHYSICIAN RECOGNIZED THAT THE ORIENTATION WAS WRONG. THE WAY [SIC] OF THE TIP OF THE CATHETER WAS ALMOST AT 2 O'CLOCK. 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 8788947 ↗
• MalfunctionJul 3, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC PROTECTOR SPHINCTEROTOME. THE USER FOUND OUT THE ORIENTATION OF THE CUTTING WIRE WAS NOT CENTERED DURING CUTTING [OF THE] DUODENAL PAPILLA, AND MAY CAUSE CUTTING POSITION NOT [TO BE]ACCURATE [INCORRECT CUTTING WIRE ORIENTATION]. 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 8757296 ↗
• MalfunctionJun 28, 2019Material Fragmentation; Material Fragmentation

  DURING A STONE REMOVAL PROCEDURE, THE PHYSICIAN USED A COOK TRI-TOME PC PROTECTOR SPHINCTEROTOME. THE CUTTING WIRE BROKE ONCE THE DEVICE WAS ELECTRIFIED [CUTTING WIRE BROKE IN ONE LOCATION]. THE USER DETECTED THE BROKEN UNDER VIEW OF ENDOSCOPY. THE USER CHANGED TO ANOTHER SAME DEVICE IMMEDIATELY TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON (B)(6) 2019: THE DEVICE WAS MISSING A PORTION OF THE CUTTING WIRE. THE INITIAL REPORTER STATED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY; HOWEVER THE LOCATION OF THE MISSING SECTION DETECTED DURING OUR LABORATORY EVALUATION IS UNKNOWN. 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 8744197 ↗
• MalfunctionMar 29, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC PROTECTOR SPHINCTEROTOME. THE USER DETECTED THAT THE WIRE GUIDE COULD NOT REACH THE DESIRED POSITION. THEN [THE USER] PULLED THE SPHINCTEROTOME FROM THE ENDOSCOPE AND FOUND OUT THAT THE CUTTING WIRE SHAPE WAS SERIOUSLY OUT OF SHAPE [TIP POINTED IN WRONG DIRECTION]. THE USER CHANGED TO A LOCAL BRAND DEVICE TO CONTINUE AND 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 8464226 ↗
• MalfunctionSep 11, 2018Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. AS REPORTED TO CUSTOMER RELATIONS: AT THE TIME, TO TRY TO CANNULATE, THE FIRST SPHINCTEROTOME HAD A BAD ORIENTATION [INCORRECT CUTTING WIRE ORIENTATION] (SEE MDR 1307905-2018-00405). SO, THE ASSISTANT THREW IT AWAY AND OPENED A BRAND NEW TRI-25M-P [TRI-TOME PC PROTECTOR SPHINCTEROTOME] WHICH HAD THE SAME PROBLEM [INCORRECT CUTTING WIRE ORIENTATION] (SUBJECT OF THIS REPORT). FINALLY, THE PHYSICIAN TRIED TO CANNULATE WITH HPC-2, [HUIBREGTSE SINGLE LUMEN NEEDLE KNIFE]. 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 7865162 ↗
• MalfunctionJul 13, 2018Failure to Align; Failure to Align

  DURING A SPHINCTEROTOMY, THE PHYSICIAN USED A COOK TRI-TOME PC PROTECTOR SPHINCTEROTOME. THE USER FOUND OUT THE CUTTING WIRE ORIENTATION IS DEVIATED [INCORRECT] AND NOT ADJUSTABLE TO CORRECT THE ORIENTATION. 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 7685276 ↗
• MalfunctionMay 4, 2018Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC PROTECTOR SPHINCTEROTOME. WHEN THE PHYSICIAN TRIED TO CANNULATE THE AMPULLA, THE TIP (NEAR THE BLACK MARKER) WAS KINKED. THE TIP COULD NOT GO IN THE RIGHT DIRECTION [INCORRECT CUTTING WIRE ORIENTATION]. THE PHYSICIAN USED ANOTHER TRI-TOME PC PROTECTOR SPHINCTEROTOME [TO COMPLETE THE PROCEDURE].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7486673 ↗
• MalfunctionFeb 27, 2018Use of Device Problem; Failure to Align; Use of Device Problem; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND ENDOSCOPIC SPHINCTEROTOMY (EST), THE PHYSICIAN USED A COOK TRI-TOME PC PROTECTOR SPHINCTEROTOME (TRI-35M-P). THE NURSE UNWRAPED THE TRI-25M-P AND CHECKED WHETHER THERE WAS A PROBLEM OR NOT. THERE WAS NO PROBLEM. THE PHYSICIAN INSERTED THE TRI-25M-P IN THE ENDOSCOPE AND ACCESSED NEAR THE AMPULLA, BUT THE TIP OF TRI-25M-P WAS NOT POINTING IN THE FITNESS DIRECTION (11'O CLOCK) [INCORRECT CUTTING WIRE ORIENTATION]. A NEW ONE WAS USED. THE ADDITIONAL QUESTIONS ANSWERED INDICATES THAT THE DIRECTION WAS NOT AT 11 O'CLOCK BUT AT 1-2 O'CLOCK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7300262 ↗
• MalfunctionDec 21, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC PROTECTOR SPHINCTEROTOME. WHEN DOING THE PAPILLOTOMY, IT WAS OBSERVED THAT THE PAPILLOTOME WAS WITH INVERTED CUT WIRE [INCORRECT CUTTING WIRE ORIENTATION], BEING NECESSARY TO DO THE SUBSTITUTION OF THE MATERIAL [USE A NEW DEVICE].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7138713 ↗
• MalfunctionDec 19, 2017Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC PROTECTOR SPHINCTEROTOME. WHEN THE PHYSICIAN DID A SPHINCTEROTOMY PROCEDURE, THE CUTTING WIRE WAS CUT [CUTTING WIRE BROKE IN ONE LOCATION]. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 11/27/2017 AND IT WAS OBSERVED THAT THE CUTTING WIRE SECURING COMPONENT SEPARATED FROM THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7130805 ↗