BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE 3-LUMEN SPHINCTEROTOME V

    MDR report key: 12363915 · Received August 25, 2021

    Report

    Report Number
    8010047-2021-10694
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Date of Event
    July 30, 2021
    Report Date
    August 25, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    PMA / PMN Number
    K950166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION AND INVESTIGATION. THE CUTTING WIRE WAS BROKEN. THE BROKEN 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 RESULTS OF CONFIRMATION OF THE DEVICE AND THE INVESTIGATION RESULTS IN THE PAST, A LIKELY MECHANISM CAUSING THE BROKEN CUTTING WIRE MIGHT BE THE FOLLOWING. THE DEVICE WAS NOT PROTRUDED ENOUGH FROM THE ENDOSCOPE UNTIL THE REAR END OF THE DUE TO THE SITUATION OF ¿1¿ DESCRIPTION, THE CUTTING WIRE AND THE ENDOSCOPE WERE BEING CLOSE TO EACH OTHER. THE OUTPUT WAS ACTIVATED IN STATE OF ¿2¿ DESCRIPTION. THIS MIGHT HAVE LED TO AN ELECTRICAL DISCHARGE BETWEEN THE CUTTING WIRE AND THE DISTAL END OF THE ENDOSCOPE. AN ELECTRICAL DISCHARGE POSSIBLY OCCURRED, AND THE CUTTING WIRE BECAME HOT INSTANTLY. THAT MIGHT HAVE CAUSED THE CUTTING WIRE TO BREAK. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE BIOMEDICAL ENGINEER THAT DURING AN ENDOSCOPIC RETROGRADE COLANGIOPANCREATOGRAPHY USING THE SUBJECT DEVICE, THE CUTTING WIRE WAS BROKEN OFF ON THE FIRST ACTIVATION. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262557 SINGLE USE 3-LUMEN SPHINCTEROTOME V SINGLE USE 2-LUMEN SPHINCTEROTOME KNS OLYMPUS MEDICAL SYSTEMS CORP. KD-V411M-0725 14K

    Patients

    Seq Age Sex Outcome Treatment
    1