Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC631Q-07301A (REF N5779330)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170399497), received between Feb 20, 2020 and Feb 20, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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.

• MalfunctionFeb 20, 2020Material Protrusion/Extrusion; Material Split, Cut or Torn; Sharp Edges; Material Protrusion/Extrusion; Material Split, Cut or Torn; Sharp Edges

  THE SERVICE CENTER RECEIVED A REPORT OF FIVE SINGLE USE SPHINCTEROTOME V DEVICES (MODEL KD-VC631Q-07301A), ALL FROM LOT NUMBER 9YV, THAT UPON INSERTION OF THE GUIDEWIRE, IT WENT THROUGH THE SIDE OF THE TOME DURING AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT ALL FIVE DEVICES MALFUNCTIONED IN THE SAME MANNER. THIS IS FOR THE FOURTH KD-VC631Q-07301A DEVICE REPORTED. IT WAS REPORTED THAT THE INTENDED PROCEDURE WAS COMPLETED WITH A NEW DEVICE AND THERE WAS NO PATIENT INJURY. THE DEVICE WAS DISCARDED UPON COMPLETION OF THE PROCEDURE AND WILL NOT BE RETURNED TO THE SERVICE CENTER FOR EVALUATION. THIS IS REPORT 4 OF 5.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9734818 ↗