BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM, 35CM, FRONT-ACTUATED GRIP

    MDR report key: 5142576 · Received October 10, 2015

    Report

    Report Number
    2951238-2015-00447
    Event Type
    Malfunction
    Date Received
    October 10, 2015
    Date of Event
    September 2, 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
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THE TEFLON PAD WAS PARTIALLY DETACHED AND METAL WAS EXPOSED. THIS TYPE OF TEFLON DAMAGE CAN RESULT FROM CONTINUOUS ACTIVATION OF THE OUTPUT WITHOUT TISSUE BETWEEN THE PROBE AND THE GRASPING SECTION. THE INSTRUCTION MANUAL CONTAINS SEVERAL WARNING STATEMENTS IN AN EFFORT TO PREVENT DAMAGE TO THE TEFLON PAD. "DO NOT ACTIVATE OUTPUT IS 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 SEPARATION MAY OCCUR."

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO UPDATE THE LOT NUMBER OF THE DEVICE AND TO PROVIDE THE DEVICE EVALUATION REPORT. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THE TEFLON PAD WAS PARTIALLY DETACHED AND METAL WAS EXPOSED. THIS TYPE OF TEFLON DAMAGE CAN RESULT FROM CONTINUOUS ACTIVATION OF THE OUTPUT WITHOUT TISSUE BETWEEN THE PROBE AND THE GRASPING SECTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE TEFLON PAD WAS REPORTED TO BE COMING OFF FROM THE HANDPIECE. IT WAS STATED THAT THE DEVICE WAS REPLACED WITH ANOTHER SIMILAR DEVICE AND THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED. OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVEN BUTT WITH NO RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672946 THUNDERBEAT 5MM, 35CM, FRONT-ACTUATED GRIP ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEM CORPORATION TB-0535FC MK911907

    Patients

    Seq Age Sex Outcome Treatment
    1