BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT ACTUATED GRIP

    MDR report key: 4857461 · Received June 19, 2015

    Report

    Report Number
    2951238-2015-00283
    Event Type
    Malfunction
    Date Received
    June 19, 2015
    Date of Event
    May 14, 2015
    Report Date
    October 9, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. THIS TYPE OF TEFLON PAD DAMAGE IS MOST LIKELY RELATED TO THE OPERATOR'S TECHNIQUE. 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." IF ADDITIONAL INFORMATION OR IF THE DEVICE IS RECEIVED AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT WILL CORRECT LOT# MK911580. THE DEVICE WAS ATTACHED TO TEST EQUIPMENT AND IT FAILED THE PROBE CHECK, AN ERROR CODE U509 WAS OBSERVED. A VISUAL INSPECTION OF THE TEFLON PAD FOUND IT TO BE SEVERELY WORN WITH CHAR MARKS OBSERVED. IT WAS ALSO NOTED THAT THE TEFLON PAD WAS SEPARATED FROM GRASPING SECTION WITH METAL EXPOSED. THE DISTAL END OF THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND A CRACK WAS FOUND ON THE DEVICE, BUT THE PROBE REMAINED INTACT. THIS TYPE OF PROBE DAMAGE IS MOST LIKELY RELATED TO THE OPERATOR'S TECHNIQUE.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE TEFLON PAD MELTED OFF THE GRASPING SECTION OF THE DEVICE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED. OLYMPUS FOLLOWED UP WITH THE USER FACILITY IN WRITING AND VIA TELEPHONE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT, BUT WITH NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400654 THUNDERBEAT 5 MM, 35 CM, FRONT ACTUATED GRIP ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEM CORPORATION TB-0535FC MK911580

    Patients

    Seq Age Sex Outcome Treatment
    1