Single Use Preloaded Sphincterotome V(Distal Wireguided) KD-VC611Q-07303SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170399442), received between Mar 16, 2023 and Dec 26, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• MalfunctionDec 26, 2025Break; Break

  IT WAS REPORTED THE SINGLE-USE SPHINCTEROTOME'S WIRE BURNT THROUGH/SNAPPED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896882 ↗
• MalfunctionSep 12, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037767 ↗
• MalfunctionMar 16, 2023Break; Break

  A CUSTOMER REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), A DOCTOR CANNULATED THE PAPILLA USING AN OLYMPUS CLEVERCUT TOME, A NURSE WAS INSTRUCTED TO BOW THE TOME AND THAT IS WHEN THE CUTTING WIRE SNAPPED. THE DOCTOR WAS ABLE TO REMOVE THE CLEVERCUT TOME AND COMPLETE THE PROCEDURE BY USING A BOSTON SCIENTIFIC JAG TOME RX 44. THERE WAS A 2-MINUTE DELAY. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. EVENT 1:2 THIS REPORT IS BEING SUBMITTED FOR THE SECOND EVENT WITH THE SUBJECT DEVICE (SINGLE USE PRELOADED SPHINCTEROTOME V) UNDER THE MEDWATCH WITH PATIENT IDENTIFIER (B)(4). THE FIRST EVENT WITH THE SUBJECT DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16561532 ↗
• MalfunctionMar 16, 2023Break; Break

  A CUSTOMER REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), A DOCTOR CANNULATED THE PAPILLA USING AN OLYMPUS CLEVERCUT TOME, A NURSE WAS INSTRUCTED TO BOW THE TOME AND THAT IS WHEN THE CUTTING WIRE SNAPPED. THE DOCTOR WAS ABLE TO REMOVE THE CLEVERCUT TOME AND COMPLETE THE PROCEDURE BY USING A BOSTON SCIENTIFIC JAG TOME RX 44. THERE WAS A 2-MINUTE DELAY. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THE SAME PRODUCT FAULT OCCURRED IN THE CASE PRIOR. THE DOCTOR MENTIONED HE FELT THE CUTTING WIRE MAY NOT HAVE BEEN FULLY EXTENDED OUT OF THE DISTAL END OF THE SCOPE. THIS MAY HAVE CAUSED THE WIRE TO BREAK WHEN THE TOME WAS BOWED. EVENT 2:2: THIS REPORT IS BEING SUBMITTED FOR THE FIRST EVENT WITH THE SUBJECT DEVICE (SINGLE USE PRELOADED SPHINCTEROTOME V) UNDER THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE SECOND EVENT WITH THE SUBJECT DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16561528 ↗