BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9220939 · Received October 22, 2019

    Report

    Report Number
    8010047-2019-03660
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Date of Event
    October 2, 2019
    Report Date
    October 22, 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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED TB-0535FCS (LOT#KR862118) WAS EVALUATED FOR ¿BROKE ON THE WORKING DISTAL TIP¿ 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 TESTING. A U509 PROBE ERROR WAS 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 ISA LARGE AMOUNT OF TISSUE BUILDUP. THE PTFE PAD (TEFLON PAD) WAS INSPECTED AND FOUND IN NORMAL WEAR CONDITION, NO ABNORMALITY WITH NO METAL EXPOSED. IN ADDITION, THE DISTAL END OF THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND FOUND APPROXIMATELY 17MM OF THE PROBE IS DETACHED, BROKEN. THE DETACHED PORTION OF THE PROBE IS RETURNED. 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, INVESTIGATION RESULTS AND SIMILAR REPORTED EVENTS, THE CAUSE FOR THE DAMAGE/BROKEN PROBE IS ATTRIBUTED TO THE PROBE COMING IN CONTACT WITH A HARD OR METALLIC SURFACE DURING ACTIVATION. AS A PREVENTIVE MEASURE, THE INSTRUCTION MANUAL STATES: THE THUNDERBEAT INSTRUMENT SHOULD BE USED FOR SOFT TISSUE. DO NOT ACTIVATE OUTPUT WHILE GRASPING HARD TISSUE SUCH AS BONE OR HIGHLY CALCIFIED TISSUE, OR HARD OBJECTS SUCH AS METAL CLIPS, STAPLER, OR OTHER INSTRUMENTS (E.G., UTERINE MANIPULATOR, FORCEPS, AND OTHERS). OTHERWISE, IT MAY CAUSE THE PROBE TIP TO BE SCRATCHED OR COME INTO DIRECT CONTACT WITH THE METAL AREA OF THE GRASPING SECTION AS THE HEAT GENERATED BY THE FRICTION BETWEEN THE HARD OBJECT AND THE PROBE TIP COULD CAUSE WEAR/DEFORMING/SPLITTING/PROTRUDING/PARTIAL SEPARATING OF THE TISSUE PAD.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY THE THUNDERBEAT TB-0535FCS HANDPIECE DISTAL WORKING TIP BROKE INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED AND NO PATIENT INJURY OR HARM WAS REPORTED. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER THUNDERBEAT DEVICE. C19188434 (SN (B)(4)), C19188435 (SN (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016396 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FCS KR862118 04953170383540

    Patients

    Seq Age Sex Outcome Treatment
    1