Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC631Q-07201S (REF N5392730)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170371417), received between Aug 8, 2022 and Oct 21, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 21, 2024Break; Break

  IT WAS REPORTED, THE SPHINCTEROTOME CUTTING WIRE SNAPPED IN HALF AND IT BROKE WITH ENERGIZATION. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20492209 ↗
• MalfunctionMay 12, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THE CUTTING WIRE OF THE SINGLE USE PRELOADED SPHINCTEROTOME V(DISTAL WIREGUIDED) BROKE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16919558 ↗
• MalfunctionAug 8, 2022Break; Break

  THE CUSTOMER REPORTED THE SUBJECT DEVICE BROKE WHILE ASSEMBLING AND WAS UNABLE TO BE USED. THE CUSTOMER WAS PREPARING THE DEVICE FOR USE AND HEARD A CRACK WHEN CONNECTING IT. WHEN THEY TRIED TO USE IT, FLUID WENT EVERYWHERE. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PLANNED PROCEDURE. THE SUBJECT DEVICE WAS SENT TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, IT WAS OBSERVED THE CUTTING WIRE FROM THE DISTAL END BROKE OFF FROM THE DISTAL END TUBE SHEATH AND THE TUBE WAS BUCKLED. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (CUTTING WIRE BROKE). THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15188243 ↗