Single Use Sphincterotome V(Distal Wireguided) KD-VC411Q-0720 (REF N5777530)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170399312), received between Nov 7, 2021 and Jul 5, 2024 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE SINGLE USE PRELOADED SPHINCTEROTOME EXHIBITED THE COVER WAS PEELED AND THE KNIFE WIRE WAS EXPOSED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19683608 ↗
• MalfunctionNov 22, 2022Break; Break

  THE CUSTOMER REPORTED THAT DURING AN ENDOSCOPIC THORACIC SYMPATHECTOMY (EST) CASE, THE KNIFE WIRE BROKE DURING THE SECOND INCISION. THE PROCEDURE WAS COMPLETED BY REPLACING IT WITH ANOTHER EQUIVALENT PRODUCT, AND NO HEALTH DAMAGE OCCURRED. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15848773 ↗
• MalfunctionAug 24, 2022Break; Break

  AS REPORTED, WHILE THE DOCTOR WAS USING KD-VC411Q-0720, THE KNIFE WIRE BROKE WHEN THE ELECTRICITY WAS APPLIED DURING THE DUODENAL PAPILLOTOMY ENDOSCOPIC SPHINCTEROTOMY (EST) THERAPEUTIC PROCEDURE. IT IS UNKNOWN WHETHER IT WAS AT THE TIME OF THE FIRST ENERGIZATION OR IT BROKE AFTER SEVERAL ENERGIZATIONS. THE DOCTOR REPLACED IT WITH ANOTHER OF THE SAME PRODUCT AND COMPLETED THE PROCEDURE. NO PATIENT HEALTH HAZARD. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. THIRD PARTY HIGH FREQUENCY ABLATION DEVICE- BIO 3 WAS USED WITH THE DEVICE. THIS EVENT INCLUDES TWO REPORTS TO ADDRESS THE TWO KNIFE WIRE THAT BROKE DURING THE CASE WITH THE SAME DEVICE MODEL (KD-VC411Q-0720). REPORT WITH PATIENT IDENTIFIER (B)(6) (LOT NUMBER UNKNOWN). REPORT WITH PATIENT IDENTIFIER (B)(6) (LOT 23K). THIS REPORT IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) (LOT 23K).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15289313 ↗
• MalfunctionDec 12, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM USER FACILITY THAT THE KNIFE BROKE WHEN ENERGIZED DURING THE ENDOSCOPIC PAPILLOTOMY (EST) PROCEDURE. ON DECEMBER 1, OMSC RECEIVED THE FOLLOWING INFORMATION OF THE PROCEDURE. THE HIGH FREQUENCY POWER SUPPLY WAS VIO300D (NON-OLYMPUS DEVICE). THE ENDOSCOPE WAS JF-260V. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12981965 ↗
• MalfunctionNov 7, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) WAS INFORMED FROM USER FACILITY THAT THE CUTTING WIRE BROKE WHEN ENERGIZED. THE DEVICE WAS REPLACED AND THE PROCEDURE CONTINUED, BUT THE SECOND DEVICE ALSO BROKE WHEN ENERGIZED. IN EACH CASE, THE CUTTING WIRE BROKE DURING THE 2-3RD ENERGIZATION, AND THE BROKEN KNIFE WIRE DID NOT FALL INTO THE PATIENT'S BODY. THE PROCEDURE WAS ALMOST COMPLETED WITH THE SECOND DEVICE, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS BY QUARRYING AS IT WAS. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. IN THE EVALUATION OF OMSC THE FOLLOWING WAS CONFIRMED, (THE FIRST DEVICE). THE CUTTING WIRE WAS BROKEN. (THE SECOND DEVICE). THE CUTTING WIRE WAS NOT BROKEN. THEREFORE, BASED ON THE EVALUATION, OMSC CONCLUDED THAT THE SECOND DEVICE WAS NOT REPORTABLE EVENT. OMSC REPORT THE MDR FOR THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12764237 ↗