Single Use 3-Lumen Sphincterotome V KD-V411M-1520 (REF N1089930)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170184079), received between Jun 1, 2023 and Jun 1, 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.

• MalfunctionJun 1, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE KNIFE WIRE WAS BROKEN AT THE FIRST ENERGIZATION DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST). THE KNIFE WIRE DID NOT FALL OUT OF THE BODY, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038282 ↗