Single Use Sphincterotome V (Distal Wireguided) KD-VC431Q-0730Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170371196), received between Mar 29, 2019 and Feb 16, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  AN OLYMPUS SALES REPRESENTATIVE (REP) REPORTED THAT HIS CUSTOMER EXPERIENCED AN OUT OF BOX FAILURE ON HIS OLYMPUS SINGLE-USE SPHINCTEROTOME V. ACCORDING TO THE REP, THE KNIFE WIRE FELL OFF UPON REMOVAL FROM THE PACKAGING. THIS EVENT HAD NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16385142 ↗
• MalfunctionMar 29, 2019Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT AT THE BEGINNING OF AN ERCP PROCEDURE DURING THE SPHINCTEROTOMY, THE WIRE ON THE CLEVERCUT SPHINCTEROTOME DISLODGED COMPLETELY FROM THE TOME. THE INTENDED PROCEDURE WAS COMPLETED WITH A NEW TOME. A 2ND DISPOSABLE GRASPING DEVICE, A RAPTOR, HAD TO BE OPENED AND USED TO RETRIEVE THE FREE FLOATING WIRE FROM THE BOWEL. A NEW CLEVERCUT WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THE WIRE FRAGMENT WAS RETRIEVED USING A DISPOSABLE RAPTOR. THE PATIENT DID NOT REQUIRE A LONGER STAY. A 1-5 MINUTES DELAY OCCURRED IN THE PROCEDURE DUE TO THE TOME AND WIRE NEEDING TO BE WITHDRAWN AND THE RAPTOR BEING INTRODUCED TO RETRIEVE THE BROKEN WIRE. THE DEVICE WAS INSPECTED PRIOR TO USE AND THERE WERE NO ANOMALIES OBSERVED. THERE WERE NO ISSUES INSERTING THE REPORTED DEVICE INTO THE PATIENT. THE MODEL/SERIAL OF THE SCOPE USED DURING THE PROCEDURE WAS AN OLYMPUS ERCP SCOPE. THERE WERE NO REPORTED ISSUES WITH THE SCOPE AND IT DID NOT NEED TO BE REPLACED DURING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8463316 ↗