BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9180345 · Received October 11, 2019

    Report

    Report Number
    8010047-2019-03568
    Event Type
    Malfunction
    Date Received
    October 11, 2019
    Date of Event
    September 20, 2019
    Report Date
    November 15, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    UDI-DI
    04953170383540
    PMA / PMN Number
    K172610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED TB-0535FCS (LOT#MK790015) WAS EVALUATED FOR ¿TEFLON PAD OF THE DEVICE PARTIALLY BURNED¿ ISSUE. THE REPORTED COMPLAINT WAS CONFIRMED. THE DEVICE ATTACHED TO THE USG-400/ESG-400. PROBE CHECK WAS PERFORMED AND THE DEVICE PASSED THE PROBE CHECK TESTING WITH NO ISSUE OBSERVED. BOTH SWITCHES WERE CHECKED AND FOUND TO BE FUNCTIONAL. IN ADDITION, VISUAL INSPECTION ON THE RECEIVED CONDITION WAS PERFORMED ON THE DEVICE AND DETERMINED THAT THERE IS SOME TISSUE BUILDUP. THE PTFE PAD (TEFLON PAD) WAS INSPECTED AND FOUND IT IS SEVERELY WORN WITH CHARRED MARKS, HOWEVER NO METAL EXPOSED WAS OBSERVED. THE DISTAL END OF THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND FOUND NO DAMAGE ON THE PROBE. THE WIPER MOVEMENT IS NOTED TO BE NORMAL AND THE CONSISTENCY OF MOVEMENT OF THE HANDLE AND JAW IS NORMAL AS WELL AS THE HANDLE LOAD. THE ROTATION OF THE KNOB TORQUE IS DETERMINED TO BE NORMAL AND SMOOTH. IN SUMMARY, BASED ON THE EVALUATION, SIMILAR EVENTS AND INVESTIGATION RESULTS, THE CAUSE OF THE WORN TEFLON PAD IS ATTRIBUTED TO NO TISSUE OR INSUFFICIENT TISSUE BETWEEN THE PROBE AND JAW WHEN THE DEVICE IS ACTIVATED. AS A PREVENTIVE MEASURE, THE INSTRUCTION MANUAL PROVIDES SEVERAL WARNING STATEMENTS IN AN EFFORT TO PREVENT DAMAGE TO THE PROBE. "DO NOT ACTIVATE OUTPUT IN SEAL AND CUT MODE WHILE THE GRASPING SECTION IS CLOSED WITHOUT CONTACTING TISSUE OR VESSEL. DO NOT ACTIVATE OUTPUT WHILE APPLYING THE PROBE TIP TO THE TISSUE WITH A STRONG FORCE. DO NOT ACTIVATE OUTPUT WHILE GRASPING THICK AND HARD TISSUES. OTHERWISE, VARIOUS FORMS OF DAMAGE IN THE PROBE TIP AND/OR THE TISSUE PAD SUCH AS PREMATURE WEAR, BREAKAGE, DEFORMATION, EXPOSURE OF METAL, AND/OR FALLING INSIDE THE BODY CAVITY, AND/OR PARTIAL SEPARATING MAY OCCUR."

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT YET BEEN RECEIVED FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED. ACCORDING TO THE INSTRUCTION MANUAL IT STATES: SHOULD ANY CRACK, SCRATCH, DEFORMATION, SPLIT, PROTRUSION, OR PARTIAL SEPARATING BE OBSERVED ON THE PROBE TIP, GRASPING SECTION, TISSUE PAD, SHAFT, THE SURFACE OF THE TRANSDUCER, TRANSDUCER CORD, OR TRANSDUCER PLUG, DO NOT USE THEM AND REPLACE THE DAMAGED INSTRUMENT OR THE TRANSDUCER WITH A SPARE. USING A DAMAGED DEVICE MAY CAUSE BURNS DUE TO ABNORMAL OUTPUT OR HIGH-FREQUENCY (RF BIPOLAR) CURRENT LEAKAGE OR BREAKAGE OF THE PROBE TIP, THE TISSUE PAD, AND THE GRASPING SECTION. THE PROBE TIP, THE TISSUE PAD, AND THE GRASPING SECTION OF THE THUNDERBEAT INSTRUMENT WEAR DUE TO ULTRASONIC VIBRATIONS. AN EXCESSIVE WEAR OCCURS DEPENDING ON THE WAY OF USE DURING THE PROCEDURE, WHICH MAY CAUSE ACCIDENTAL DESTRUCTION OR DETERIORATION OF COAGULATING, COAGULATING/CUTTING, SEALING, OR SEALING/CUTTING PERFORMANCES. TO AVOID SUCH AN EVENT, BE SURE TO PREPARE A SPARE THUNDERBEAT INSTRUMENT, TORQUE WRENCH, AND STABILIZER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THERAPEUTIC TLH (TOTAL LAPAROSCOPIC HYSTERECTOMY) PROCEDURE, THE TEFLON PAD OF THE DEVICE WAS PARTIALLY BURNED. THERE WAS NO PATIENT HARM OR INJURY REPORTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974420 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FCS MK790015 04953170383540

    Patients

    Seq Age Sex Outcome Treatment
    1