Single Use Preloaded Sphincterotome V KD-V631M-07201SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170403163), received between May 5, 2022 and Apr 4, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2023Break; Sparking; Break; Sparking

  THE CUSTOMER REPORTED TO OLYMPUS THAT, DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, THE CUTTING WIRE OF THEIR SINGLE USE PRELOADED SPHINCTEROTOME V (CLEVERCUT 3V) DEVICE TOUCHED THE 0.025 VISIGLIDE GUIDE WIRE (WHICH WAS SET INSIDE THE PANCREATIC DUCT INDEPENDENTLY) AND CAUSED A SPARK THAT BROKE THE SPHINCTEROTOME CUTTING WIRE. THE WIRE REMAINED INTACT, AND THERE WAS NO NEED TO EXTRACT ANY FOREIGN BODY OBJECTS FROM THE PATIENT AS A RESULT. THE DAMAGED WIRE WAS REMOVED AND REPLACED TO CORRECT THE PROBLEM, AND THE REPLACEMENT OF THE DEVICE PROLONGED THE PROCEDURE BY 1 TO 2 MINUTES. THE PATIENT WAS ANAESTHETIZED AT THIS TIME. THE CUSTOMER DISPOSED OF THE COMPLAINT DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16678354 ↗
• MalfunctionMay 5, 2022Break; Break

  A USER FACILITY REPORTED TO OLYMPUS THAT THE WIRE BROKE DURING A PROCEDURE. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS. THIS IS REPORT #2 OF 2 DUE TO MULTIPLE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14287993 ↗
• MalfunctionMay 5, 2022Break; Break

  A USER FACILITY REPORTED TO OLYMPUS THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAM PROCEDURE, THE WIRE BROKE. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14287779 ↗