Single Use 3-Lumen Sphincterotome V KD-V431M-0720 (UDI 04953170382680)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170382680), received between Dec 27, 2019 and Jul 21, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2023Sparking; Material Split, Cut or Torn; Sparking; Material Split, Cut or Torn

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE 3-LUMEN SPHINCTEROTOME V HAD ITS CUTTING WIRE BREAK WHEN THE GENERATOR WAS CONNECTED TO GET ENERGY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17372357 ↗
• MalfunctionMar 22, 2023Break; Break

  UPON FOLLOW UP, IT WAS REPORTED THAT THE PATIENT WAS NOT EXAMINED WITH XRAY OR OTHER IMAGING TECHNIQUE AND NO INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16589216 ↗
• MalfunctionMay 12, 2022Break; Break

  A USER FACILITY REPORTED TO OLYMPUS THAT THE KNIFE WIRE BROKE DURING AN ENDOSCOPIC SPHINCTEROTOMY PROCEDURE AND THE POWER WAS TURNED ON. THE DEVICE WAS REPLACED AND THE PROCEDURE COMPLETED. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14378148 ↗
• MalfunctionOct 13, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE HEALTH PROFESSIONAL THAT DURING INSPECTION OF THE SUBJECT DEVICE BEFORE USE, THE WIRE KNIFE WAS BROKEN OFF DURING ACTIVATION. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THE SUBJECT DEVICE WAS USED IN COMBINATION WITH ANOTHER COMPANY'S ELECTROSURGICAL UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12622308 ↗
• MalfunctionDec 27, 2019Break; Break

  THE SERVICE CENTER WAS INFORMED THAT ONE SINGLE USE 3-LUMEN SPHINCTEROTOME V CUTTING WIRE (KD-V431M-0720) WAS OBSERVED TO BE CUT IN THE CENTER WHEN THE WIRE WAS REMOVED FROM THE SCOPE. THE PHYSICIAN WAS PERFORMING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WHEN THE PHYSICIAN REQUESTED THAT THE TECHNICIAN BEND THE TOME. IT WAS REPORTED THERE WAS NO RESPONSE TO THE DISTAL END AS IT WAS NOT BENDING. UPON REMOVAL OF THE DEVICE, THE OBSERVATION WAS MADE THAT THE CENTER OF THE CUTTING WIRE WAS SEPARATED/DETACHED. IT WAS REPORTED THE PHYSICIAN COMPLETED THE PROCEDURE AS NORMALLY AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9527485 ↗