Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC611Q-07301S (REF N5392330)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04953170371332), received between Oct 29, 2020 and Apr 5, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2024Break; Break

  IT WAS REPORTED THE SINGLE USE PRELOADED SPINCTEROTOME EXPERIENCED BREAKAGE OF THE CUTTING WIRE. THE ISSUE OCCURRED DURING A THERAPEUTIC SPHINCTEROTOMY PROCEDURE. THE THERAPEUTIC PROCEDURE WAS COMPLETED WITH NO DELAY OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19048253 ↗
• MalfunctionMar 19, 2024Break; Break

  IT WAS REPORTED THE SINGLE USE PRELOADED SPHINCTEROTOME CUTTING WIRE BROKE. THE ISSUE OCCURRED DURING A SPHINCTEROTOMY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18935638 ↗
• MalfunctionMar 18, 2024Break; Peeled/Delaminated; Break; Peeled/Delaminated

  IT WAS REPORTED THAT THE SUBJECT DEVICE¿S CUTTING WIRE BROKE. THE ISSUE OCCURRED DURING A THERAPEUTIC SPHINCTEROTOMY. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE AND THERE WERE NO REPORTS OF DELAYS OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924062 ↗
• MalfunctionFeb 15, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THE CUTTING WIRE PROTECTION OF THE SINGLE USE PRELOADED SPHINCTEROTOME WAS ON THE DISTAL PART OF THE DEVICE AND THE THERAPEUTIC SPHINCTEROTOMY WAS UNABLE TO BE PERFORMED. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18710522 ↗
• MalfunctionMar 3, 2022Break; Break

  BREAKAGE OF THE CUTTING WIRE OF THE SPHINCTEROTOME DURING A DIGESTIVE ENDOSCOPY PROCEDURE WAS REPORTED. ACCORDING TO THE REPORT, THIS INCIDENT HAS OCCURRED REPEATEDLY WITH DIFFERENT LOT NUMBERS (LOT NUMBER 14V AND 15V). INCREASED IN PROCEDURE (UNKNOWN TIME) WAS REPORTED DUE TO DEVICE CHANGE HOWEVER, THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. THIS REPORT IS FOR LOT 15V. THIS REPORT IS RELATED TO A REPORT WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13661112 ↗
• MalfunctionMar 3, 2022Break; Break

  BREAKAGE OF THE CUTTING WIRE OF THE SPHINCTEROTOME DURING A DIGESTIVE ENDOSCOPY PROCEDURE WAS REPORTED. ACCORDING TO THE REPORT, THIS INCIDENT HAS OCCURRED REPEATEDLY WITH DIFFERENT LOT NUMBERS (LOT NUMBER 14V AND 15V). INCREASED PROCEDURE TIME (UNKNOWN TIME) WAS REPORTED DUE TO DEVICE CHANGE HOWEVER, THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. THIS REPORT IS FOR LOT 14V. THIS REPORT IS RELATED TO A REPORT WITH PATIENT (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13660953 ↗
• MalfunctionMay 12, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE HEALTH PROFESSIONAL THAT DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) USING THE SUBJECT DEVICE, THE CUTTING WIRE WAS BROKEN. THERE WERE NO MISSING PARTS. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810531 ↗
• MalfunctionOct 29, 2020Break; Break

  WE RECEIVED THE FOLLOWING REPORT. IT WAS IMPOSSIBLE TO SLIDE THE SPHINCTEROTOME (THE SUBJECT DEVICE) OVER THE GUIDEWIRE. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. ON AUGUST 31, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE CUTTING WIRE WAS SNAPPED, AND THAT THE BROKEN SECTION OF THE CUTTING WIRE WAS MELTED AND BURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10753446 ↗