Single Use Preloaded Sphincterotome V(Distal Wireguided) KD-VC631Q-07203S (REF N5394330)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170371738), received between Dec 22, 2021 and May 3, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AT THE TIME OF THE SPHINCTEROTOMY DURING BOWING, THE WIRE OF THE SINGLE USE PRELOADED SPHINCTEROTOME BROKE AT THE AMPULLA INSIDE THE PATIENT IN THE SCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19244241 ↗
• MalfunctionOct 18, 2022Break; Flare or Flash; Break; Flare or Flash

  DEVICE WAS REPORTED TO FAIL UPON INITIAL CLINICAL USE. OLYMPUS AREA SALESPERSON CUSTOMER REPRESENTATIVE (REP.) REPORTED THE CUTTING WIRE OF THE KD-VC631Q-07203S HAD BROKEN AND BURN IN HALF AT THE DISTAL DURING A THERAPEUTIC UNSPECIFIED PROCEDURE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621892 ↗
• MalfunctionOct 18, 2022Break; Flare or Flash; Break; Flare or Flash

  DEVICE WAS REPORTED TO FAIL UPON INITIAL CLINICAL USE. OLYMPUS AREA SALESPERSON CUSTOMER REPRESENTATIVE (REP.) REPORTED THE CUTTING WIRE OF THE KD-VC631Q-07203S HAD BROKEN AND BURN IN HALF AT THE DISTAL DURING A PROCEDURE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621881 ↗
• MalfunctionDec 22, 2021Break; Break

  THE CUSTOMER REPORTED THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE, WHILE INSIDE THE PATIENT THE SPHINCTEROTOME WAS ACTIVATED AND THE GUIDEWIRE BROKE AT THE PROXIMAL END. THE WIRE REMAINED ATTACHED AT THE DISTAL END; HOWEVER, COULD NOT BE RETRACTED THROUGH THE UNIT. THE WIRE FORMED A HOOK SHAPE WHICH CONCERNED THE DOCTOR. THE SPHINCTEROTOME WAS SUCCESSFULLY EXTRACTED FROM THE PATIENT BY PULLING THE WIRE INTO THE SCOPE AND WITHDRAWING THE SCOPE FROM THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13059774 ↗