BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT OPEN FINE JAW TYPE X

    MDR report key: 20158460 · Received September 6, 2024

    Report

    Report Number
    9614641-2024-01788
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    July 1, 2024
    Report Date
    September 10, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    UDI-DI
    04953170435829
    PMA / PMN Number
    K211838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE ERROR AND PROBE BREAKAGE OCCURRED DUE TO CONTACT WITH A SURGICAL INSTRUMENT OR THE NON-INSULATED AREA OF THE GRASPING SECTION. THE POSSIBLE MECHANISMS ARE AS FOLLOWS: DURING SEAL & CUT MODE OUTPUT ACTIVATION, THE PROBE CAME INTO CONTACT WITH HARD TISSUE, METAL, OR A SURGICAL INSTRUMENT, RESULTING IN A SCRATCH ON THE PROBE AND CAUSING THE SEAL & CUT SHORT CIRCUIT ERROR. SEAL & CUT MODE WAS ACTIVATED WHEN THE GRASPING SECTION WAS CLOSED WITHOUT GRASPING TISSUE (THIS INCLUDES AFTER TISSUE RESECTION). THIS RESULTED IN WEAR ON THE TISSUE PAD. DUE TO THE WEAR OF THE TISSUE PAD, THE NON-INSULATED AREA OF THE GRASPING SECTION CAME INTO CONTACT WITH THE PROBE. IN ADDITION, A SEAL & CUT SHORT CIRCUIT ERROR (ERROR CODE: U508) OCCURRED. SEAL & CUT MODE WAS ACTIVATED UNDER THE DESCRIBED CONDITION, AND SCRATCHES (CONTACT MARKS) WERE GENERATED WHEN THE PROBE CONTACTED THE DISTAL END OF THE GRASPING SECTION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE ULTRASONIC SURGICAL DEVICE EXHIBITED PEELING OF THE TISSUE PAD. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2073219 THUNDERBEAT OPEN FINE JAW TYPE X ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0009OFX 3ZK27 04953170435829

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown