BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 4757410 · Received May 7, 2015

    Report

    Report Number
    2951238-2015-00218
    Event Type
    Malfunction
    Date Received
    May 7, 2015
    Date of Event
    April 13, 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

    THIS SUPPLEMENTAL REPORT WILL CORRECT LOT TO LOT# MK911607. A VISUAL INSPECTION OF THE DEVICE FOUND THAT THE TEFLON PAD WAS SLIGHTLY MELTED AND PARTIALLY SPLIT ON THE DISTAL END OF THE GRASPING SECTION. THERE WAS ALSO A SMALL PORTION OF THE TEFLON PAD THAT WAS LIFTED OFF THE SIDE OF THE GRASPING SECTION, BUT THERE WAS NO METAL EXPOSED.

    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 AND PROBE. "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.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A RIGHT HEMICOLECTOMY PROCEDURE, THE TEFLON PAD MELTED. THERE WAS NO PATIENT INJURY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A DIFFERENT BUT SIMILAR DEVICE. OLYMPUS MADE MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT BUT WITH NO RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301090 OLYMPUS THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEM CORPORATION TB-0535FC MK911607

    Patients

    Seq Age Sex Outcome Treatment
    1