BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT ACTUATED GRIP

    MDR report key: 4857457 · Received June 19, 2015

    Report

    Report Number
    2951238-2015-00284
    Event Type
    Malfunction
    Date Received
    June 19, 2015
    Date of Event
    May 26, 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

    LOT# MK911601. A VISUAL INSPECTION OF THE TEFLON PAD FOUND IT TO BE SLIGHTLY MELTED ON THE TIP OF THE GRASPING SECTION, BUT NO METAL EXPOSED. THE DISTAL END OF THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND FOUND NO VISUAL INDICATION OF DAMAGE TO THE PROBE UNIT. IT WAS NOTED THAT THE WIPER HAD NO MOVEMENT DUE TO TISSUE BUILD UP AND THE CONSISTENCY OF MOVEMENT OF THE HANDLE AND JAW WAS TIGHT AND STUCK. THE HANDLE COULD NOT BE OPERATED DUE TO TISSUE BUILD UP AT WIPER SECTION. THE DEVICE WILL BE SENT TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR FURTHER INVESTIGATION. IF ADDITIONAL OR SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    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 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 ACCORDINGLY.

    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. IT WAS REPORTED THAT NO DEVICE FRAGMENTS FELL INTO THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED. OLYMPUS FOLLOWED UP WITH THE USER FACILITY AND WAS INFORMED THAT THE DEVICE WAS TESTED PRIOR TO THE PROCEDURE BY THE NURSE AND NO ABNORMALITIES WERE FOUND. HOWEVER, LIMITED INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400380 THUNDERBEAT 5 MM, 35 CM, FRONT ACTUATED GRIP ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEM CORPORATION TB-0535FC MK911601

    Patients

    Seq Age Sex Outcome Treatment
    1