BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9173162 · Received October 9, 2019

    Report

    Report Number
    8010047-2019-03545
    Event Type
    Malfunction
    Date Received
    October 9, 2019
    Date of Event
    September 25, 2019
    Report Date
    October 9, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED FOR EVALUATION. THE RETURNED TB-0535FC (LOT# KR850754) WAS EVALUATED DUE TO "PROBE DAMAGE ERROR" ISSUE. THE REPORTED COMPLAINT WAS NOT CONFIRMED. VISUAL INSPECTION NOTED THAT THE DEVICE ATTACHED TO THE USG-400/ESG-400. A PROBE CHECK WAS PERFORMED AND THE DEVICE PASSED THE PROBE CHECK TESTING. 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 HAS SEPARATED WITH CHARRED MARKS OBSERVED, HOWEVER NO METAL EXPOSED WAS NOTED. 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. THE DISTAL END OF THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND FOUND NO VISUAL INDICATION OF DAMAGE TO THE PROBE TIP. IN SUMMARY, THE REPORTED COMPLAINT WAS NOT ABLE TO CONFIRM AS THE DEVICE OPERATES NORMAL WITH NO SIGNS OF ERROR CODES OR ABNORMALITIES.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE THUNDERBEAT TB-0535FC IMMEDIATELY GAVE A PROBE DAMAGE ERROR WHEN PLUG IN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO PATIENT HARM OR INJURY WAS REPORTED. PRODUCT RETURN NOTED THAT THE TEFLON PAD WAS SEPARATED WITH CHARRED MARKS ON THE PROBE WHEN INSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967098 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FCS KR850754 04953170383540

    Patients

    Seq Age Sex Outcome Treatment
    1