Single Use Sphincterotome V(Distal Wireguided) KD-VC411Q-0730 (REF N5391330)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170371134), received between Oct 27, 2023 and Jul 23, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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.

• MalfunctionJul 23, 2024Break; Break

  IT WAS REPORTED, THE SINGLE USE PRELOADED SPHINCTEROTOME. THE KNIFE WIRE WAS BROKEN. THE ISSUE WAS FOUND, DURING AN ENDOSCOPIC SPHINCTEROTOMY THERAPEUTIC PROCEDURE. WHEN PERFORMING AN ELECTROCUTION, FOR PYLORUS RESECTION. THE DEVICE WAS REMOVED. AND THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE WITHOUT DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19806681 ↗
• MalfunctionFeb 15, 2024Thermal Decomposition of Device; Melted; Material Split, Cut or Torn; Thermal Decomposition of Device; Melted; Material Split, Cut or Torn

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COATED PORTION OF THE SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED) CUTTING WIRE WAS TORN, AND THE BROKEN PORTION WAS SCORCHED AND MELTED FROM TOUCHING METAL WHEN ACTIVATED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711213 ↗
• MalfunctionOct 27, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDE) FELL OFF. THE ISSUE WAS FOUND DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18022181 ↗