Single Use Sphincterotome V(Distal Wireguided) KD-VC411Q-0330 (REF N5777430)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170399305), received between Jan 17, 2023 and Jan 17, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.

• MalfunctionJan 17, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THAT, DURING A SPHINCTEROTOMY, THE METALLIC CUTTING WIRE ON THE SUBJECT DEVICE WAS CUT WHEN ENERGIZED PREVENTING THE POSSIBILITY OF A COMPLEMENTARY CUT. THE SPHINCTEROTOMY HAD ALREADY BEEN PERFORMED CORRECTLY BUT COULD NOT BE COMPLETED WITH THE SUBJECT DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16188244 ↗