BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED)

    MDR report key: 12089958 · Received June 30, 2021

    Report

    Report Number
    8010047-2021-08166
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 2, 2021
    Report Date
    June 30, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR INVESTIGATION. THE CUTTING WIRE WAS BROKEN. THE BREAKING PORTION WAS SCORCHED AND MELTED. THE OUTER DIAMETER OF THE CUTTING WIRE WAS MEASURED. THE RESULT INDICATED NO ABNORMALITIES. THE LENGTH OF THE COATED PORTION OF THE CUTTING WIRE, AND THE CUTTING WIRE ITSELF PRESENTED NO ABNORMALITIES. THERE WERE NO MISSING PARTS IN THE SUBJECT DEVICE. OTHER ABNORMALITIES THAT COULD LEAD TO THE BREAKAGE OF THE CUTTING WIRE WERE NOT CONFIRMED. NO ABNORMALITIES WERE DETECTED IN THE DEVICE HISTORY RECORD WITH THE LOT NUMBER FOR THE FOLLOWING INSPECTION ITEMS WHICH RELATED TO THE REPORTED PHENOMENON. LENGTH OF CUTTING WIRE. LENGTH OF COATED PORTION. OPERATION OF CUTTING WIRE. BASED ON THE CONFIRMATION RESULT AND THE INVESTIGATION RESULTS IN THE PAST, A LIKELY MECHANISM CAUSING THE BROKEN CUTTING WIRE MIGHT BE THE FOLLOWING. HIGH FREQUENCY CURRENT WAS APPLIED BETWEEN THE CUTTING WIRE AND THE TISSUE AT THE POINT OF THE CONTACT. AS A RESULT, THE CURRENT DENSITY AT THE CONTACT AREA INCREASED, AND THE CUTTING WIRE BECAME INSTANTLY HOT. AVOIDING THE SITUATIONS DESCRIBED ABOVE WILL PREVENT THE CUTTING WIRE FROM BREAKING. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY A BIOMEDICAL ENGINEER THAT DURING AN ENDOSCOPIC SPHINCTEROTOMY USING THE SUBJECT DEVICE, THE KNIFE WIRE WAS BROKEN OFF ON ACTIVATION. THE SURGEON CHANGED ANOTHER DEVICE, BUT THE KNIFE WIRE WAS BROKEN OFF, TOO. IN ADDITION, THE SURGEON CHANGED, BUT THE KNIFE WIRE WAS BROKEN OFF, TOO. THE INTENDED PROCEDURE WAS COMPLETED WITH THE OTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE FIRST BROKEN KNIFE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993578 SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED) SINGLE USE PRELOADED SPHINCTEROTOME KNS OLYMPUS MEDICAL SYSTEMS CORP. KD-VC411Q-0725 11K

    Patients

    Seq Age Sex Outcome Treatment
    1