Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC631Q-07301S (REF N5393130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170371493), received between Dec 14, 2022 and Oct 27, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2023Component Missing; Tear, Rip or Hole in Device Packaging; Component Missing; Tear, Rip or Hole in Device Packaging

  THE CUSTOMER REPORTED TO OLYMPUS, DURING PROCEDURE, THE CUTTING WIRE OF THE SPHINCTEROTOME BROKE WHEN THE ELECTRIC SCALPEL WAS USED. UPON INSPECTION OF THE CUSTOMER¿S RETURNED DEVICE IT WAS OBSERVED, THE COATED PORTION OF THE CUTTING WIRE WAS TORN, AND PART OF THE CUTTING WIRE WAS MISSING. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18021572 ↗
• MalfunctionSep 22, 2023Break; Break

  THE CUSTOMER REPORTED THAT THE CUTTING WIRE BROKE DURING A SPHINCTEROTOMY. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798458 ↗
• MalfunctionDec 14, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED), THE CUTTING WIRE BROKE. THE ISSUE OCCURRED DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THERE WAS NO DELAY, AND THE THERAPEUTIC PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15977016 ↗