BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9347459 · Received November 20, 2019

    Report

    Report Number
    8010047-2019-04031
    Event Type
    Malfunction
    Date Received
    November 20, 2019
    Date of Event
    October 10, 2019
    Report Date
    February 25, 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

    THE RETURNED TB-0535FCS (LOT#KR862118) WAS RECEIVED FOR EVALUATION. THE DEVICE ATTACHED TO THE USG-400/ESG-400, PROBE CHECK WAS PERFORMED AND THE DEVICE FAILED THE PROBE CHECK TESTING. BOTH SWITCHES WERE CHECKED AND FOUND TO BE FUNCTIONAL. 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 NORMAL WEAR WITH NO METAL EXPOSED. THE DISTAL END OF THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND FOUND THE PROBE IS DETACHED AND THE MISSING PORTION WAS NOT RETURNED FOR EVALUATION. 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. BASED ON THE EVALUATION, THE DAMAGE PROBE IS ATTRIBUTED TO THE PROBE COMING IN CONTACT WITH HARD OR METALLIC SURFACE DURING ACTIVATION.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT YET BEEN RECEIVED FOR EVALUATION. THE 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. 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."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ERROR MESSAGE OCCURRED ON A THUNDERBEAT DEVICE DURING A TOTAL HYSTERECTOMY BY SCOPIA AND COLPOSACROPEXIE PROCEDURE. THE USER CLEANED THE PROBE AND DEVICE BROKE DURING CLEANING. A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142386 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