BEUDAMED
    FDA Adverse Event Death Summary report: N

    PEAK PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2792402 · Received October 3, 2012

    Report

    Report Number
    3007069406-2012-00249
    Event Type
    Death
    Date Received
    October 3, 2012
    Date of Event
    December 24, 2010
    Report Date
    December 24, 2010
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS DISCOVERED DURING A REVIEW OF PRODUCT ORDER FORMS THAT WERE SENT BY A SALES REP EMPLOYED BY A DISTRIBUTOR THAT WAS LEAVING THE MFR. THE PT WAS BROUGHT INTO SURGERY AFTER HITTING HIS HEAD DURING A FALL. THE PLASMABLADE WAS ONLY USED TO MAKE THE INITIAL INCISION OF THE SKIN ON THE SKULL. ONCE THE SKULL WAS PULLED BACK TO REVEAL THE BRAIN, BLOOD FLOWED DROM THE BRAIN. THE BLEEDING COULD NOT STOPPED AND THE PT EXPIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "PT DIED DURING CASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEAK PLASMABLADE TISSUE DISSECTION DEVICE GEI MEDTRONIC ADVANCED ENERGY LLC BLASMABLADE 4.0 34485

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death