Single Use 3-Lumen Sphincterotome V KD-V431M-0720 (REF N5411930)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04953170380631), received between Oct 19, 2018 and Dec 18, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE SINGLE USE 2-LUMEN SPHINCTEROTOME'S COATING THAT SHOULD ENVELOP THE WIRE WAS MISSING. THE ISSUE OCCURRED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE AND WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838175 ↗
• MalfunctionSep 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THE SINGLE USE 3-LUMEN SPHINCTEROTOME CUTTING WIRE BROKE. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP)PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952069 ↗
• MalfunctionAug 8, 2025Failure to Fire; Failure to Fire

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22747622 ↗
• MalfunctionMar 30, 2024Break; Break

  IT WAS REPORTED THE LUMEN SPHINCTEROTOME KNIFE BROKE WHEN ELECTRICITY WAS APPLIED. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC THORACIC SYMPATHECTOMY (ETS) SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING IT WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19009012 ↗
• MalfunctionAug 8, 2023Material Deformation; Material Deformation

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SINGLE USE 3-LUMEN SPHINCTEROTOME V WIRE KNIFE WAS CUT OFF DURING A PROCEDURE. THERE WAS NO EFFECT ON THE PATIENT. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS EVALUATED, AND IT WAS FOUND THE KNIFE WIRE WAS DAMAGED. THIS MDR (MEDICAL DEVICE REPORT) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484297 ↗
• MalfunctionJul 3, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE KNIFE WIRE OF THE SINGLE USE 3-LUMEN SPHINCTEROTOME V WAS TURNED TO THE 1 O'CLOCK DIRECTION INSTEAD OF THE 11 O'CLOCK DIRECTION. THIS OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE AND THERE WAS NO REPORT OF PATIENT HARM. THE DEVICE WAS RETURNED, EVALUATED, AND IT WAS FOUND THAT THE COVER WAS PEELED, LEAVING THE WIRE EXPOSED. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17247278 ↗
• MalfunctionApr 25, 2023Break; Break

  AS REPORTED FOR THIS EVENT BY THE DISTRIBUTOR, DURING AN UNKNOWN THERAPEUTIC PROCEDURE, WHEN THE KNIFE WIRE OF THE 3-LUMEN SPHINCTEROTOME V DEVICE WAS STRETCHED OVER DUODENAL PAPILLA, THE KNIFE WIRE DID NOT TURN IN DESIRED DIRECTION. DESPITE REPEATED ADJUSTMENT OF THE DIRECTION BY TIGHTENING AND LOOSENING THE KNIFE WIRE. SUBSEQUENTLY, THE KNIFE WIRE BROKE INSIDE THE PATIENT BODY. HOWEVER, NO PART OF THE DEVICE FELL OFF. THE PROCEDURE WAS COMPLETED USING A NEW SIMILAR DEVICE. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811193 ↗
• MalfunctionOct 6, 2022Break; Break

  AS REPORTED, DURING A THERAPEUTIC ENDOSCOPIC PAPILLOTOMY, THE KNIFE BROKE DURING CUTTING (DURING OUTPUT). THE WIRE DID NOT FALL OFF. THE DEVICE WAS REPLACED WITH SIMILAR DEVICE AND THE INTENDED PROCEDURE WAS COMPLETED WITH NO HARM OR INJURY TO THE PATIENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15554494 ↗
• InjuryDec 23, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: DURING AN ERCP WITH SPHINCTEROTOMY, THE SURGEON HAD DIFFICULTY CUTTING. AFTER REPEATED ATTEMPTS TO CUT, THE BLADE BROKE AND WAS RETRIEVED WITH AN UNKNOWN INSTRUMENT. THE INTENDED SURGERY WAS COMPLETED WITH A SIMILAR NON-OLYMPUS DEVICE. THE CUSTOMER REPORTED NO PROCEDURAL DELAY DUE TO THIS DEVICE MALFUNCTION.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13069894 ↗
• MalfunctionNov 7, 2018Break; Break

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE SPHINCTEROTOME V CUTTING WIRE BROKE. THERE WAS NO REPORT OF THE DEVICE FRAGMENT FALLING INTO THE PATIENT. THE GENERATOR SETTINGS WERE EFFECT 2/ CUT 2 AND VALVE 3. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8049030 ↗
• MalfunctionOct 19, 2018Break; Break

  OLYMPUS WAS INFORMED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE WIRE OF THE FIRST BROKE WHILE INSIDE THE PATIENT; HOWEVER, REMAINED ATTACHED TO THE TOME. IT WAS CONFIRMED THAT NO DEVICE FRAGMENT FELL INTO THE PATIENT. THERE WAS NO CURRENT FLOWING WHEN THE WIRE BROKE. A SECOND TOME USED AND WOULD NOT BOW (BEND OR FLEX) PROPERLY AND BECAME STUCK IN THE 3 O'CLOCK POSITION. IT WAS REPORTED THAT THE WIRE WAS ONLY ARCHING A LITTLE BIT. THERE WAS MINIMAL DELAY AS THE DOCTOR SWITCHED TO A THIRD DIFFERENT DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY REPORTED. ADDITIONALLY, THE USER FACILITY REPORTED THAT THE DEVICES WERE INSPECTED PRIOR TO USE NO VISUAL ANOMALIES NOTED. THE DEVICES ARE STORED IN AN ELECTRONIC CLOSET IN THE PROCEDURE ROOM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7987507 ↗