BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE X

    MDR report key: 8806260 · Received July 19, 2019

    Report

    Report Number
    8010047-2019-02602
    Event Type
    Malfunction
    Date Received
    July 19, 2019
    Date of Event
    July 2, 2019
    Report Date
    July 19, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    UDI-DI
    04953170392207
    PMA / PMN Number
    K180575
    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. THE PROBE HAD A MARK CONTACTED WITH THE GRASPING SECTION. THE GRASPING SECTION HAD A MARK CONTACTED WITH THE PROBE. THE TISSUE PAD OF THE SUBJECT DEVICE WAS SEVERELY WORN. THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THE DEVICE HISTORY 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 A LAPAROSCOPIC ASSISTED DISTAL GASTRECTOMY, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, SEAL & CUT SHORT CIRCUIT ERROR (U508 ERROR) OCCURRED AND THE USER FOUND THE TISSUE PAD OF THE SUBJECT DEVICE WAS WORN. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON JULY 17, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE TISSUE PAD WAS SEVERELY WORN AND THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE SEVERELY WORN TISSUE PAD AND THE MISSING OF THE PROBE COATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601040 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE X ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FCX 92K 04953170392207

    Patients

    Seq Age Sex Outcome Treatment
    1