Single Use Sphincterotome V(Distal Wireguided) KD-VC411Q-0730 (REF N5777630)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170399329), received between Sep 18, 2021 and Sep 18, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jan 7, 2026Class IIOpen, Classified

   Devices which did not undergo thermoforming could deform and lose performance.

   Z-1279-2026 · Root cause: Process control · Recall details · FDA record ↗

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.

• MalfunctionSep 18, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM USER FACILITY THAT THE CUTTING WIRE BROKE BEFORE THE END OF THE SPHINCTEROTOMY DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE OMSC CONFIRMED THE FOLLOWING EVENT ON (B)(6) 2021 AND DETERMINED THAT IT WAS AN MEDICAL DEVICE REPORT (MDR) REPORTABLE EVENT. THE KNIFE WIRE WAS BROKEN WITH ENERGIZATION. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12493166 ↗