Single Use Sphincterotome V(Distal Wireguided) KD-VC431Q-0720 (REF N5391530)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170371172), received between Aug 10, 2022 and May 9, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9, 2024Break; Break

  IT WAS REPORTED THE SPHINCTEROTOME WAS PRELOADED AND THE CUTTING/CAUTER SNAPPED WHEN INITIATED. THE ISSUE OCCURRED DURING A DIAGNOSTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THE PATIENT WAS SEDATED AND THERE WAS A 5-MINUTE DELAY IN THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281667 ↗
• MalfunctionMay 7, 2024Break; Break

  IT WAS REPORTED THE SPHINCTEROTOME EXPERIENCED SPLITTING OF THE CUTTING/CAUTER GUIDEWIRE. THE ISSUE OCCURRED DURING A DIAGNOSTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264980 ↗
• MalfunctionFeb 27, 2024Break; Break

  IT WAS REPORTED, THE IT WAS REPORTED, THE SINGLE USE SPHINCTEROTOME V'S CUTTING WIRE BROKE. THE ISSUE OCCURRED AT THE BEGINNING OF AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18789976 ↗
• MalfunctionAug 10, 2022Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THE CUTTING WIRE ON THE SUBJECT DEVICE BROKE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE CUTTING WIRE WAS DAMAGED WITH NO SPARKS OBSERVED AND WAS STILL IN ONE PIECE. THE PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THE SUBJECT DEVICE WAS SENT TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, THE CUTTING WIRE WAS FOUND TO BE DAMAGED AND THE COATING ON THE WIRE WAS DAMAGED. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (DAMAGE TO CUTTING WIRE). THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15198227 ↗