BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT ACTUATED GRIP

    MDR report key: 5148175 · Received October 14, 2015

    Report

    Report Number
    2951238-2015-00486
    Event Type
    Malfunction
    Date Received
    October 14, 2015
    Date of Event
    September 23, 2015
    Report Date
    October 27, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION AND THE EVALUATION IS PENDING. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. THIS TYPE OF PROBE 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 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." IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT LOT# TO MK951565, CORRECT MANUFACTURING DATE, AND TO PROVIDE THE DEVICE EVALUATION RESULTS. THE EVALUATION CONFIRMED THE REPORTED PHENOMENON OF A BROKEN PROBE. THE DISTAL END OF THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND FOUND THE PROBE DETACHED, AND THE MISSING PORTION WAS NOT RETURNED. A PROBE CHECK WAS PERFORMED AND THE DEVICE FAILED. ERROR CODE U509 WAS OBSERVED. A VISUAL INSPECTION FOUND THAT THE TEFLON PAD HAD NORMAL WEAR, WITH NO METAL EXPOSED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE THE PROBE SNAPPED OFF AND FELL INSIDE THE PATIENT. THE DEVICE FRAGMENTS WERE SUCCESSFULLY RETRIEVED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED. 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
    681512 THUNDERBEAT 5 MM, 35 CM, FRONT ACTUATED GRIP ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEM CORPORATION TB-0535FC MK951565

    Patients

    Seq Age Sex Outcome Treatment
    1