BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9285741 · Received November 6, 2019

    Report

    Report Number
    8010047-2019-03868
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Date of Event
    October 11, 2019
    Report Date
    January 8, 2020
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT #1 UPDATES THE FOLLOWING SECTION: D10,G4,G7,H2,H3,H4,H6 AND H10. THE RETURNED TB-0535FCS (LOT#KR862118) WAS EVALUATED FOR ¿TEFLON PAD BURNT¿ ISSUE. THE DEVICE ATTACHED TO THE USG-400/ESG-400. 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 IS BURNT AT THE TOP SECTION AND A PIECE MISSING WITH METAL EXPOSED OBSERVED. THE DISTAL END OF THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND FOUND CHARRED MARKS TO THE PROBE UNIT. 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 INVESTIGATION RESULTS, THE DAMAGE TEFLON PAD IS ATTRIBUTED TO NO TISSUE OR INSUFFICIENT TISSUE BETWEEN THE PROBE AND JAW WHEN THE DEVICE IS ACTIVATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE FOLLOWING DEVICE EVALUATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE, THE TEFLON PAD OF THE DEVICE PARTIALLY BURNED. THE INTENDED PROCEDURE WAS COMPLETED WITH A NEW HANDPIECE DEVICE. NO OTHER EQUIPMENT WAS REPLACED DURING PROCEDURE. NO PATIENT INJURY REPORTED. THE DOCTOR WAS PERFORMING A SEAL AND CUT DURING PROCEDURE. NO DEVICE FRAGMENT FELL INSIDE THE PATIENT. NO PATIENT BLEEDING CAUSED BY THIS EVENT. THE VISUAL DAMAGE WAS THAT THE MELTED TEFLON PAD. VERY LITTLE METAL EXPOSED ON THE DEVICE JAW. THE GENERATOR SETTINGS WERE 2:1. THE CONNECTION POINTS TO THE GENERATOR WERE INSPECTED AND NO CABLE DAMAGE WAS OBSERVED. THE PHYSICIAN IS EXPERIENCED IN USING THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080814 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FCS KR862104 04953170383540

    Patients

    Seq Age Sex Outcome Treatment
    1