Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC631Q-07201S (REF N5779030)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170399466), received between Mar 16, 2023 and Jun 27, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2025Break; Break

  IT WAS REPORTED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE CUTTING WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK UP DEVICE. THERE WERE NO REPORT PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350573 ↗
• MalfunctionFeb 16, 2024Break; Break

  IT WAS REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE KNIFE WIRE BROKE OFF FROM THE CATHETER. IT WAS REPORTED THERE WAS A 30 SECOND TO 1 MINUTE DELAY DURING THE PROCEDURE AND THERE WAS NO INJURY OR HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18722996 ↗
• MalfunctionJul 26, 2023Break; Break

  THE CUSTOMER REPORTED THAT DURING A SPHINCTEROTOMY PROCEDURE, THE CUTTING WIRE ON HIS OLYMPUS SINGLE-USE PRELOADED SPINCTEROTOME V WAS BROKEN AT THE DISTAL END. ACCORDING TO THE INITIAL REPORTER, NO NOISE WAS HEARD, BUT THE CABLE WAS FELT TO HAVE BEEN SEVERED WHEN THE HANDLE WAS MANIPULATED. REPORTEDLY, THIS EVENT DID NOT RESULT IN ANY PATIENT HARM. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT. THIS COMPLAINT IS RELATED TO REPORTS WITH PATIENT IDENTIFIERS: (B)(6) & (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17395878 ↗
• MalfunctionJul 25, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE PRELOADED SPHINCTEROTOME V(DISTAL WIREGUIDED) CUTTING WIRE BROKE AT THE DISTAL END. THE CABLE WAS FELT TO BE SEVERED WHEN THE HANDLE WAS MANIPULATED. THE ISSUE OCCURRED DURING PROCEDURE AND THE INTENDED PROCEDURE WAS SPHINCTEROTOMY. THERE WERE NO REPORTS OF PATIENT HARM. RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393707 ↗
• MalfunctionJul 25, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED) CUTTING WIRE BROKE AT THE DISTAL END. THE CABLE WAS FELT TO BE SEVERED WHEN THE HANDLE WAS MANIPULATED. THE ISSUE OCCURRED DURING PROCEDURE AND THE INTENDED PROCEDURE WAS SPHINCTEROTOMY. THERE WERE NO REPORTS OF PATIENT HARM. RELATED PATIENT IDENTIFIERS: (B)(6) AND (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393639 ↗
• MalfunctionMar 16, 2023Break; Break

  AS REPORTED, DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WHEN THE DOCTOR DECIDED TO CUT THE AMPULLA (SPHINCTEROTOMY), THE CUTTING WIRE BROKE SUDDENLY WHEN PUSHED ON THE PADDLE OF THE ELECTROCAUTERY. THE DOCTOR WAS NOT ABLE TO CUT THE AMPULLA. NO INJURIES TO THE PATIENT. NOTHING LEFT IN THE PATIENT (WIRE), CONFIRM BY X-RAY. THE DOCTOR CHANGED THAT TOME AND TAKE ANOTHER ONE FROM BOSTON SCIENTIFIC (JAGTOME). THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE . SLIGHT DELAY (UNSPECIFIC DELAY) WAS REPORTED, HOWEVER, NO IMPACT TO THE PATIENT, NO HARM WAS REPORTED, NO PATIENT INJURY, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16561576 ↗