Single Use Preloaded Sphincterotome V KD-V631M-07202S (REF N5787630)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170403187), received between Aug 27, 2021 and Mar 12, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Break

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24581339 ↗
• MalfunctionAug 8, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT THE CUTTING WIRE (KNIFE WIRE) BROKE. ONE END OF THE CUTTING WIRE (THE ACTUAL KNIFE) BROKE OFF ¿ IT WAS STILL HANGING BY THE OTHER END. THE REPORTED ISSUE WAS OBSERVED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE PROCEDURE AND ANESTHESIA WERE PROLONGED BY A FEW MINUTES. THERE WAS NO REPORT OF PATIENT OR USER INJURY DUE TO THE EVENT. THE SUBJECT DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE COVER WAS PEELED, AND THE KNIFE WIRE WAS EXPOSED. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING DEVICE EVALUATION (COVER PEELED OFF).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17483993 ↗
• MalfunctionMar 17, 2022Break; Device Fell; Break; Device Fell

  IT WAS REPORTED THE CUSTOMER TRIED TO UTILIZE THE MAIN HANDLE, HANDLE WOULD NOT MOVE AND WIRE FELL OUT. THE DEVICE WAS REPLACED AND THE INTENDED PROCEDURE WAS COMPLETED WITH A SECOND LIKE DEVICE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13796794 ↗
• MalfunctionAug 27, 2021Unintended Movement; Unintended Movement

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPORTER. THE ISSUE OCCURRED IN THE MIDDLE OF THE PROCEDURE. THE SAME DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS INSPECTED PRIOR TO USE AND WAS WORKING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12376871 ↗