BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEAK PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2800054 · Received October 17, 2012

    Report

    Report Number
    3007069406-2012-00238
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE, CATALOG NUMBER AND LOT NUMBER ARE NOT KNOWN, A REVIEW OF THE LOT HISTORY RECORD CANNOT BE PERFORMED. END OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNK DISPOSABLE DEVICE GAVE AN ERROR MESSAGE OF "GENERATOR DOES NOT RECOGNIZE HANDPIECE". THIS WAS DISCOVERED DURING A REVIEW OF AN OLDER COMPLAINT FILE. SINCE THE DEVICE, CATALOG NUMBER, LOT NUMBER ARE UNK AND THE RESOLUTION TO THE COMPLAINT AND PT STATUS CANNOT BE VERIFIED, THIS MDR IS BEING FILED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1