Single Use Sphincterotome V KD-VC433Q-0730 (REF N5778130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170399374), received between Aug 7, 2023 and Aug 7, 2023 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2023Break; Break

  THE CUSTOMER REPORTED THAT HIS OLYMPUS SINGLE-USE SPHINCTEROTOME V BROKE DURING AN EST PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PHYSICIAN APPLIED ELECTRICITY APPROXIMATELY 3 TIMES, BUT THE CHARGE STOPPED COMING THROUGH. REPORTEDLY, THAT¿S WHEN IT WAS DISCOVERED THAT THE KNIFE WAS BROKEN. THE CUSTOMER CONFIRMED THAT THIS EVENT HAD NO HEALTH IMPACT ON THE PATIENT AND THAT THE PAPILLARY INCISION HAD ALREADY BEEN COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17470161 ↗