BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT OPEN FINE JAW

    MDR report key: 4853626 · Received June 15, 2015

    Report

    Report Number
    8010047-2015-00435
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Date of Event
    May 8, 2015
    Report Date
    May 21, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPIC MEDICAL SYSTEMS CORP. (OMSC) FOR EVAL. THE EVAL CONFIRMED THAT THE PTFE PAD WAS PARTIALLY PEELED. THE MANUFACTURING RECORD WAS REVIEWED WITH NO IRREGULARITIES. AS A RESULT OF THE INVESTIGATION, IT IS HIGHLY LIKELY THAT THE PTFE PAD WAS PEELED SINCE THE USER CONTINUED ACTIVATING OUTPUT WITHOUT CONTACTING TISSUE (INCLUDING AFTER THE TISSUE ALREADY CUT) FOR AN EXTENDED TIME. THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE ALREADY STATES; WARNINGS: DO NOT ACTIVATE OUTPUT IN SEAL AND CUT MODE WHILE THE GRASPING SECTION IS CLOSED WITHOUT CONTACTING TISSUE OR VESSEL, OR ENSURING THAT TISSUE IS TRANSECTED. OTHERWISE, A LOCAL INCREASE OF THE TEMPERATURE DUE TO A FRICTION BETWEEN THE PROBE TIP AND THE GRASPING SECTION MAY RESULT IN VARIOUS FORMS OF DAMAGE IN THE PROBE TIP AND/OR THE PTFE PAD, SUCH AS PREMATURE WEAR, BREAKAGE, DEFORMATION, AND/OR FALLING OFF INSIDE THE BODY CAVITY AND/OR PARTIAL SEPARATING. THIS REPORT IS BEING SUBMITTED AS MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE SUBJECT DEVICE WAS USED DURING A THYROIDECTOMY. THE PTFE PAD WAS SEPARATED WHEN THE PROCEDURE WAS FINISHED. THE PROCEDURE WAS COMPLETED WITH THE SUBJECT DEVICE. THERE WAS NOT PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389942 THUNDERBEAT OPEN FINE JAW THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0009OF 51K 20

    Patients

    Seq Age Sex Outcome Treatment
    1