Tri-Tome pc G22554Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00827002225541), received between Mar 11, 2016 and Sep 1, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (24 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 27 reports, 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 ↗
• 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 ↗
• MalfunctionOct 22, 2019Failure to Align; Failure to Align

  DURING AN STENT IMPLANTATION PROCEDURE, THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. THE USER ADVANCED THE DEVICE TO DUODENAL PAPILLA, PULLED THE WIRE GUIDE AND FOUND THE ORIENTATION WAS POINTING AT 2-3 O'CLOCK [INCORRECT CUTTING WIRE ORIENTATION]. THE USER TRIED TO ADJUST THE ORIENTATION BUT FAILED. 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 9220655 ↗
• MalfunctionAug 2, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. THE PATIENT UNDERWENT AN ERCP DUE TO GALLSTONES. THE PHYSICIAN INFORMED THAT WHEN INSERTING THE SPHINCTEROTOME, IT PRESENTED ABNORMAL CURVATURE [INCORRECT CUTTING WIRE ORIENTATION]. IT WAS NECESSARY TO OPEN A NEW SPHINCTEROTOME TO COMPLETE THE PROCEDURE. THE FOLLOWING INFORMATION WAS RECEIVED ON 01-AUG-2019: WHEN EXPOSED [ADVANCED] THE SPHINCTEROTOME WAS ANGLED TO THE OPPOSITE SIDE THAT IT SHOULD [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 8857484 ↗
• MalfunctionMar 7, 2019Failure to Align; Failure to Align

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. THE MATERIAL PRESENTED DEFORMITY AT THE DISTAL TIP (CUTTING WIRE). IT WAS TOTALLY MISALIGNED (INCORRECT CUTTING WIRE ORIENTATION), NOT ALLOWING THE CORRECT USE OF THE PRODUCT. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8401595 ↗
• 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 PHYSICIAN INFORMED [STATED] THAT WHEN INSERTING THE SPHINCTEROTOME, IT DID NOT ANGULATE CORRECTLY [INCORRECT CUTTING WIRE ORIENTATION], ALWAYS TURNING TO THE OPPOSITE SIDE. IT WAS NECESSARY TO OPEN A NEW SPHINCTEROTOME. 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 8237606 ↗
• MalfunctionOct 3, 2018Break; Break

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED THREE (3) COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOMES. DURING AN ERCP, THE CUTTING WIRE OF THREE (3) TRI-25 MELTED DOWN DURING THE PROCEDURE AS THE PHYSICIAN SAID IN HIS REPORT, HE ALSO SENT THE ELECTROSURGICAL MACHINE BRAND AND SETTINGS. PER THE PHYSICIAN'S HANDWRITTEN NOTE: WHILE PERFORMING AN ERCP WE HAD AN ISSUE WITH COOK SPHINCTEROTOMES. THEY WERE IMMEDIATELY MELTING AT THE LEVEL OF THE CUTTING METALLIC THREAD [CUTTING WIRE] DESPITE USING REGULAR ELECTROCAUTERY SETTINGS. THE THREE (3) SPHINCTEROTOMES WERE FROM THE SAME LOT. THE CAUTERY SETTINGS WERE THE FOLLOWING: ELECTROSURGICAL DEVICE- SPECTRUM SUPPLIER UNIT, MODE: MONOCUT, EFFECT 4 POWER 100; MODE: FORCED COAG, EFFECT 4, POWER 60. CHANGING TO ANOTHER SPHINCTEROTOME FROM ANOTHER MANUFACTURER SOLVED THE PROBLEM AND DID NOT EXPOSE TO THE SAME PROBLEM. ADDITIONAL INFORMATION WAS RECEIVED ON 01-OCT-2018 FROM THE COOK SALES REPRESENTATIVE: "I JUST CONTACTED THE PHYSICIAN THAT ATTENDED THE CASE AND HE CONFIRMED THAT NO PORTION [OF THE CUTTING WIRE] REMAINED IN THE PATIENT." A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PAT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7931391 ↗
• MalfunctionSep 11, 2018Failure to Align; Failure to Align

  DURING A SPHINCTEROTOMY, THE PHYSICIAN USED A TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. AS REPORTED TO CUSTOMER RELATIONS: "WHEN OPENING THE MATERIAL TO PERFORM THE PROCEDURE, THE PHYSICIAN FOUND THAT THE SPHINCTEROTOME TRIPLE LUMEN HAD A METAL ROD A LITTLE SHORTER THAN NORMAL PROVIDING A DEFECTIVE CAMBER [INCORRECT CUTTING WIRE ORIENTATION] AND MAKING IT IMPOSSIBLE TO ACCESS THE PAPILLA AND SUBSEQUENT CANALIZATION." PICTURES PROVIDED BY THE FACILITY SHOW THAT THE ORIENTATION OF THE CUTTING WIRE IS INCORRECT (SUBJECT OF THIS 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 7865983 ↗
• MalfunctionJun 28, 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 WAS ADVANCED INTO 4.2 MM BIOPSY ACCESS ENDOSCOPE ACCESSORY CHANNEL. THE OPERATOR FOUND THAT THE CUTTING WIRE WAS POINTING AT 2 O'CLOCK. THERE WERE MULTIPLE ATTEMPTS TO ADJUST THE ORIENTATION OF THE CUTTING WIRE AND THEY FAILED. AT LAST, THE OPERATOR REPLACED ANOTHER OF THE SAME PRODUCT TO FINISH 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 7648449 ↗
• MalfunctionMar 27, 2018Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. THE PHYSICIAN, VERY EXPERIENCED AND FAMILIAR USER OF COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOMES, ATTEMPTED SPHINCTEROTOMY. [THE ATTEMPTED SPHINCTEROTOMY] FAILED BECAUSE OF INCONVENIENT ORIENTATION [INCORRECT CUTTING WIRE ORIENTATION]. DESPITE THE THREE-DIMENSIONAL FORMING STYLET, THE ORIENTATION WAS VERY BAD. INSTEAD OF 12 O¿ CLOCK, THE SPHINCTEROTOME FACED 3 O¿ CLOCK (SUBJECT OF THIS REPORT). THE PHYSICIAN REMOVED THE SPHINCTEROTOME AND COMPLETED THE PROCESS USING ANOTHER SPHINCTEROTOME. THE PHYSICIAN COMPLAINS THAT THE SAME INCIDENT HAS HAPPENED SEVERAL TIMES WITH THE TRI-25 (MDR REPORT 1037905-2018-00117) AND TRI-30 (MDR REPORT 1037905-2018-00118).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7375659 ↗
• MalfunctionJan 8, 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 WAS ADVANCED INTO A 4.2 MM BIOPSY ACCESS IN ENDOSCOPY [4.2 MM ENDOSCOPE ACCESSORY CHANNEL], WHILE THE OPERATOR FOUND THAT THE CUTTING WIRE WAS POINTING AT 3 O'CLOCK. THERE WERE MULTIPLE ATTEMPTS TO ADJUST THE ORIENTATION OF THE CUTTING WIRE AND IT FAILED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7171632 ↗
• MalfunctionSep 8, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE THE PHYSICIAN USED A TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. DURING THE ERCP, THE SURGEON REMOVED THE MATERIAL FROM THE PACKAGE, UNROLLING AND STRAIGHTENING IT. HOWEVER, WHEN [THE MATERIAL WAS ANGLED], IT WAS OBSERVED THAT IT ANGLED TO THE OPPOSITE SIDE [INCORRECT CUTTING WIRE ORIENTATION]. IT WAS FOUND TO BE KNEADED, NOT RETURNING COMPLETELY TO ITS ORIGINAL POSITION (SEE RELATED MDR 1037905-2017-00581). IT WAS NECESSARY TO USE A NEW MATERIAL, WHICH PRESENTED THE SAME DEFECT ("ANGLED TO THE OPPOSITE SIDE") [INCORRECT CUTTING WIRE ORIENTATION] (SUBJECT OF THIS REPORT). THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2017: THE DEVICES WERE USED. THE EVENT OCCURRED WHEN THE DEVICE WAS PLACED DOWN THE ENDOSCOPE, BUT THE SPHINCTEROTOME PRESENTED PROBLEMS OF MIS-ORIENTATION UPON BOWING THE DISTAL END, BEFORE THE CANNULATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6851404 ↗
• MalfunctionSep 8, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE THE PHYSICIAN USED A TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. DURING THE ERCP, THE SURGEON REMOVED THE MATERIAL FROM THE PACKAGE, UNROLLING AND STRAIGHTENING IT. HOWEVER, WHEN [THE MATERIAL WAS ANGLED], IT WAS OBSERVED THAT IT ANGLED TO THE OPPOSITE SIDE [INCORRECT CUTTING WIRE ORIENTATION]. IT WAS FOUND TO BE KNEADED, NOT RETURNING COMPLETELY TO ITS ORIGINAL POSITION (SUBJECT OF THIS REPORT). IT WAS NECESSARY TO USE A NEW MATERIAL, WHICH PRESENTED THE SAME DEFECT ("ANGLED TO THE OPPOSITE SIDE") [INCORRECT CUTTING WIRE ORIENTATION] (SEE RELATED MDR 1037905-2017-00582). THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 8/28/17: THE DEVICES WERE USED. THE EVENT OCCURRED WHEN THE DEVICE WAS PLACED DOWN THE ENDOSCOPE, BUT THE SPHINCTEROTOME PRESENTED PROBLEMS OF MIS-ORIENTATION UPON BOWING THE DISTAL END, BEFORE THE CANNULATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6851385 ↗
• MalfunctionJun 12, 2017Failure 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: "THE DEVICE WAS PLACED DOWN THE SCOPE BUT HAD BAD ORIENTATION. [THEY] ATTEMPTED MULTIPLE TIMES TO REINTRODUCE. THEY HAD TO GET ANOTHER DEVICE FOR THE PROCEDURE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6633209 ↗
• MalfunctionApr 10, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME THE PAPILLOTOME WHILE LOADING FELL WAY TO THE LEFT AND COULDN'T BE USED. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED ON 3/20/17: THE CUTTING WIRE, WHEN PUT UNDER TENSION, TURNS THE TIP TO THE LEFT, SO THAT THERE´S NO CANNULATION POSSIBLE [INCORRECT CUTTING WIRE ORIENTATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6477585 ↗
• MalfunctionJan 3, 2017Failure to Align; Failure to Align

  DURING PREPARATION FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. THE DOCTOR STATED THAT THE SPHINCTEROTOME WAS NOT IN CONDITION FOR USE BECAUSE OF IT'S TIP DEFORMITY. THE CATHETER HAD NO IDEAL CURVATURE [INCORRECT CUTTING WIRE ORIENTATION] TO PERFORM THE PAPILLOTOMY. TO FINALIZE THE PROCEDURE, A NEW PRODUCT WAS OPENED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6219614 ↗
• MalfunctionSep 16, 2016Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. "WHEN USING THE FIRST SPHINCTEROTOME, IT HAD AN IRREGULAR ANGLE [INCORRECT CUTTING WIRE ORIENTATION] (MDR REPORT NUMBER 1037905-2016-00364). UPON OPENING AND USING OF ANOTHER DEVICE, AND OCCURRED THE SAME DEFECT [SECOND DEVICE ALSO HAD INCORRECT CUTTING WIRE ORIENTATION] (SEE MDR REPORT NUMBER 1037905-2016-00365). BOTH DEVICES WERE DISCARDED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5955829 ↗
• MalfunctionSep 16, 2016Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. "WHEN USING THE FIRST SPHINCTEROTOME, IT HAD AN IRREGULAR ANGLE [INCORRECT CUTTING WIRE ORIENTATION] (SEE MDR REPORT NUMBER 1037905-2016-00364). UPON OPENING AND USING OF ANOTHER DEVICE, AND OCCURRED THE SAME DEFECT [SECOND DEVICE ALSO HAD INCORRECT CUTTING WIRE ORIENTATION]. BOTH DEVICES WERE DISCARDED." (MDR REPORT NUMBER 1037905-2016-00365).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5955828 ↗
• MalfunctionSep 15, 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 PRESENTED IRREGULAR ANGULATION [INCORRECT CUTTING WIRE ORIENTATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5954429 ↗
• MalfunctionSep 15, 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 PRESENTED IRREGULAR ANGULATION [INCORRECT CUTTING WIRE ORIENTATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5954413 ↗
• MalfunctionMay 27, 2016Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. "PHYSICIANS REPORT THAT THE DISTAL TIP DOESN'T HAVE THE ORIENTATION THAT THEY NEEDED." THIS WAS INITIALLY REPORTED TO BE PRIOR TO USE. ON 05/04/2016, WE RECEIVED THE FOLLOWING INFORMATION: THEY NOTICED THE MISORIENTATION BEFORE INSERTING THE SPHINCTEROTOME INTO THE ENDOSCOPE. THE TIP OF THE SPHINCTEROTOME WAS APPROXIMATELY THREE (3) CM OUT OF THE ENDOSCOPE [USED AFTER NOTICING MISORIENTATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5684860 ↗
• MalfunctionMay 19, 2016Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. "PHYSICIANS REPORT THAT THE DISTAL TIP DOESN'T HAVE THE ORIENTATION THAT THEY NEEDED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5667968 ↗
• MalfunctionMay 19, 2016Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. "PHYSICIANS REPORT THAT THE DISTAL TIP DOESN´T HAVE THE ORIENTATION THAT THEY NEEDED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5667967 ↗
• MalfunctionMay 19, 2016Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. "PHYSICIANS REPORT THAT THE DISTAL TIP DOESN'T HAVE THE ORIENTATION THAT THEY NEEDED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5667966 ↗
• MalfunctionMar 11, 2016Failure to Align; Failure to Align

  ON 02/12/2016, WE RECEIVED THE FOLLOWING INFORMATION: DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. THE PHYSICIANS REPORT THAT THE DISTAL TIP DOES NOT HAVE THE ORIENTATION THAT THEY NEEDED [INCORRECT CUTTING WIRE ORIENTATION]. THIS EVENT WAS REPORTED TO BE PRIOR TO USE. ON 02/16/2016, WE RECEIVED NEW INFORMATION THAT THIS OCCURRED ONCE THE SPHINCTEROTOME WAS DOWN THE ENDOSCOPE [USED].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5494652 ↗