BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9188415 · Received October 14, 2019

    Report

    Report Number
    8010047-2019-03570
    Event Type
    Malfunction
    Date Received
    October 14, 2019
    Date of Event
    September 24, 2019
    Report Date
    October 14, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    UDI-DI
    04953170409677
    PMA / PMN Number
    K172610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    1 OF 2 (MW#19070). DEVICE WAS RETURNED FOR EVALUATION. THE RETURNED TB-0535FC (LOT#KR852192) WAS EVALUATED DUE TO ¿BROKEN PROBE¿ ISSUE. THE REPORTED COMPLAINT WAS CONFIRMED. VISUAL INSPECTION NOTED THAT THE DEVICE ATTACHED TO THE USG-400/ESG-400. PROBE CHECK WAS PERFORMED AND THE DEVICE FAILED THE PROBE CHECK WITH ERROR CODE U509 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 WORN WITH NO METAL EXPOSED. THE DISTAL END OF THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND FOUND 17MM OF THE PROBE WAS DETACHED. THE DETACHED PROBE WAS NOT RETURNED. ADDITIONALLY, 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, AND SIMILAR REPORTED EVENTS, THE CAUSE FOR THE DETACHED ON THE PROBE IS ATTRIBUTED TO PROBE COMING INTO CONTACT WITH A HARD OR METALLIC SURFACE DURING ACTIVATION. THE WORN TEFLON PAD FOUND 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". RELATED COMPLAINTS: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE CUSTOMER EXPERIENCED PROBE DAMAGE ERRORS ON TWO TB-0535FCS FORCEPS OF THE SAME LOT # KR852192. BOTH ERRORS OCCURRED ON THE SAME PROCEDURE AND HAPPENED TOWARDS THE END OF THE CASE. THE PROCEDURE WAS COMPLETED WITHOUT ANY ERROR USING A THIRD TB-0535FCS. THE DEVICE BROKE DURING THE BACK HALF OF THE PROCEDURE AND THE METAL WAS EXPOSED, HOWEVER, THERE WAS NO VISIBLE SPARKING, CHARRING OBSERVED. IT WAS ALSO REPORTED THAT A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED USING A LAPAROSCOPIC GRASPER. THERE WAS NO BLEEDING, NO PATIENT HARM OR INJURY REPORTED AND THERE WAS NO OTHER EQUIPMENT REPLACED DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980083 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FCS KR852192 04953170409677

    Patients

    Seq Age Sex Outcome Treatment
    1