Single Use Sphincterotome V(Distal Wireguided) KD-VC412Q-0215 (REF N5777730)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170399336), received between Apr 13, 2022 and Jul 9, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K160241); they may or may not involve this specific model.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2024Break; Break

  IT WAS REPORTED THAT THE WIRE OF THE SINGLE USE PRELOADED SPHINCTEROTOME BROKE WHEN ELECTRICITY WAS APPLIED. IT DID NOT FALL OFF. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19700848 ↗
• MalfunctionSep 28, 2023Fracture; Fracture

  A CUSTOMER REPORTED TO OLYMPUS, DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST), THE KNIFE WIRE TIP BROKE AT THE TIMING OF OUTPUT. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17840813 ↗
• MalfunctionAug 24, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED) WAS INSPECTED BEFORE USE AND THE COVERING WAS TORN, EXPOSING THE KNIFE WIRE. THE ISSUE WAS FOUND DURING PROCEDURE, AND THE THERAPEUTIC PROCEDURE (ENDOSCOPIC SPHINCTEROTOMY) WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612540 ↗
• MalfunctionDec 22, 2022Break; Break

  AN OLYMPUS SALES REP REPORTED ON BEHALF OF THE CUSTOMER, THE CUTTING WIRE (SINGLE USE SPHINCTEROTOME V) BROKE DURING A THERAPEUTIC SPHINCTEROTOMY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16035577 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED DOES THE USE OF LOW OSMOLALITY CONTRAST MEDIUM REDUCE THE FREQUENCY OF POST-ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PANCREATITIS: A COMPARATIVE STUDY BETWEEN USE OF LOW AND HIGH OSMOLALITY CONTRAST MEDIA,¿ PATIENTS EXPERIENCED ADVERSE EVENTS AFTER ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PR-4Q-1. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS KD-VC412Q-0215. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS FG-V435P. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS JF-260V. STUDY AIM: EVALUATE THE USEFUL NESS OF IODIXANOL FOR PREVENTION PEP IN COMPARISON WITH MEGLUMINE AMIDOTRIZOATE. METHOD: TWO HUNDRED AND NINETY-ONE PATIENTS WERE ENROLLED AND DIVIDED INTO THE 2 GROUPS ACCORDING TO THE CONTRAST MEDIUM USED. ONE HUNDRED AND FIFTY-FIVE PATIENTS UNDERWENT ERCP WITH MEGLUMINE AMIDOTRIZOATE, AND 136 PATIENTS UNDERWENT ERCP WITH IODIXANOL. THE PRIMARY OUTCOME OF THIS STUDY WAS THE INCIDENCE OF PEP ASSOCIATED WITH THE USE OF EACH CONTRAST MEDIUM. RESULTS: IN THIS STUDY, COMPARISON OF THE MEGLUMINE AMIDOTRIZOATE TREATMENT AND IODIXANOL TREATMENT GROUPS SHOWED NO SIGN

  Patient problems: Pancreatitis; Unspecified Hepatic or Biliary Problem

  MAUDE report 14102113 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160241. One submission often covers many models, so check the product and lot details in each record.

• Z-1282-2026 · Jan 7, 2026 · Open, Classified
  Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software Version: N/A Product Description: These instruments have been