BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP TYPE S

    MDR report key: 8665090 · Received June 3, 2019

    Report

    Report Number
    8010047-2019-02088
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 17, 2019
    Report Date
    June 4, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    PMA / PMN Number
    K172610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE TISSUE PAD OF THE SUBJECT DEVICE WAS PARTIALLY SEPARATED. THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. BASED ON THE PAST SIMILAR CASES, IT WAS KNOWN THAT THE COATING FOR ELECTRIC INSULATION OF THE PROBE AND THE TISSUE PAD WERE DAMAGED SINCE THE USER CONTINUED TO ACTIVATE OUTPUT WITHOUT GRASPING TISSUE (INCLUDING AFTER THE TISSUE ALREADY CUT). THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL AS FOLLOWS: DO NOT ACTIVATE OUTPUT IN SEAL & CUT MODE WHILE THE GRASPING SECTION IS CLOSED WITHOUT CONTACTING TISSUE OR VESSEL, OR ENSURING THAT TISSUE IS TRANSECTED. OTHERWISE, A LOCAL INCREASE OF THE TEMPERATURE DUE TO A FRICTION BETWEEN THE PROBE TIP AND THE GRASPING SECTION MAY RESULT IN VARIOUS FORMS OF DAMAGE IN THE PROBE TIP AND/OR THE TISSUE PAD, SUCH AS PREMATURE WEAR, BREAKAGE, DEFORMATION, AND/OR FALLING OFF INSIDE THE BODY CAVITY AND/OR PARTIAL SEPARATING.

    Description of Event or Problem · 1

    DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED. THE TISSUE PAD OF THE SUBJECT DEVICE WAS PARTIALLY SEPARATED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON MAY 27, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE TISSUE PAD WAS PARTIALLY SEPARATED, AND THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE SEPARATION OF THE TISSUE PAD AND THE MISSING OF THE PROBE COATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456662 THUNDERBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0520FCS 8XK

    Patients

    Seq Age Sex Outcome Treatment
    1