BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8707291 · Received June 18, 2019

    Report

    Report Number
    2951238-2019-00950
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Date of Event
    May 22, 2019
    Report Date
    June 18, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE SERVICE CENTER FOR EVALUATION. THE DEVICE WAS ATTACHED TO THE USG-400/ESG-400 AND PROBE FUNCTIONALITY WAS CHECKED. THE DEVICE FAILED THE PROBE CHECK WITH AN ERROR CODE U509. BOTH SWITCHES WERE CHECKED AND FOUND TO BE FUNCTIONAL. A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE AND FOUND THERE IS FOREIGN MATERIAL BUILD UP. 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 17MM OF THE PROBE DETACHED. THE WIPER MOVEMENT AND THE CONSISTENCY OF MOVEMENT OF THE HANDLE AND JAW WAS NORMAL. THE HANDLE LOAD IS NORMAL. THE ROTATION OF THE KNOB TORQUE IS NORMAL AND SMOOTH. BASED ON SIMILAR REPORTS, A PROBABLE CAUSE FOR THIS TYPE OF TEFLON PAD DAMAGE IS OPERATOR¿S TECHNIQUE IN WHICH INSUFFICIENT TISSUE IS GRASPED BETWEEN THE PROBE AND THE JAW. AS PART OF OUR INVESTIGATION, THE SERVICE CENTER FOLLOW UP WITH THE SALES REPRESENTATIVE (REP) STATING THE PROBE WAS STILL ATTACHED WHEN IT WAS REMOVED FROM THE PATIENT AND BECAME DETACHED OUTSIDE THE PATIENT BODY. NO DEVICE FRAGMENT FELL INSIDE THE PATIENT. ADDITIONALLY, THE SALES REP REPORTED THAT THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITIES OBSERVED. ALL CONNECTIONS POINT TO THE GENERATOR WERE INSPECTED AND THE SETTING WAS 2:2. THE INSTRUCTION MANUAL CONTAINS SEVERAL WARNING STATEMENTS IN AN EFFORT TO PREVENT DAMAGE TO THE TEFLON PAD. "DO NOT TO 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

    THE SERVICE CENTER WAS INFORMED DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE THE THUNDERBEAT HAND PIECE HAD A PROBE DAMAGE ERRORS AND FAILED DURING THE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE. AFTER THE PROCEDURE THE HAND PIECE WAS INSPECTED AND THE PROBE FELL OFF. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502409 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FCS PW305502 04953170409677

    Patients

    Seq Age Sex Outcome Treatment
    1