BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM, 35MM, FRONT -ACTUATED GRIP

    MDR report key: 3874374 · Received April 18, 2014

    Report

    Report Number
    2951238-2014-00158
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Removal / Correction Number
    Z-0432-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL CONFIRMED THE USER'S REPORTED PHENOMENON OF PROBE DAMAGE. A PROBE CHECK WAS PERFORMED AND THE DEVICE FAILED THE PROBE CHECK, ALSO BOTH SWITCHES WERE CHECKED AND BOTH HAD FAILED. DURING INSPECTION, A FRACTURE WAS NOTED ON THE PROBE. THE PTFE PAD (TEFLON PAD) WAS INSPECTED AND WAS FOUND TO BE IN GOOD CONDITION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A LAP SUPRACERVICAL HYSTERECTOMY (LSH) PROCEDURE, THE DEVICE ULTRASONIC PROBE FAILED AND SEPARATED FROM THE DEVICE. THE ULTRASONIC PROBE WAS LOCATED AND SUCCESSFULLY REMOVED FROM THE PT'S PERITONEAL CAVITY W/O ANY HARM TO THE PT. IT IS UNK IF THE DEVICE WAS PROBE CHECKED PRIOR TO PROCEDURE, AND IF THE "PROBE DAMAGE ERROR" WAS NOTED PRIOR TO THE PROBE FAILURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THE REPORT BUT WITH NO RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238452 THUNDERBEAT 5MM, 35MM, FRONT -ACTUATED GRIP ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEM CORPORATION TB-0535FC K4120

    Patients

    Seq Age Sex Outcome Treatment
    1