BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2822325 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00168
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MANUFACTURER FOR THE TIME PERIOD (B)(4) 2010 THROUGH (B)(4) 2012. AFTER DECONTAMINATION AND CLEANING OF THE RETURNED DEVICE, VISUAL INSPECTION OF THE DEVICE REVEALED NO DEFECTS TO THE HANDLE AND TIP. THE BUTTON DID NOT HAVE INTERMITTENT FAILURE. THE DEVICE RESPONDED WHEN THE CUT/COAG BUTTONS WERE PRESSED. THE RETURNED PLASMABLADE 4.0 WAS FOUND FULLY FUNCTIONAL WITHOUT ANY ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED MIDWAY THROUGH A MASTECTOMY CASE, THE HANDPIECE QUIT WORKING; THERE WAS NO COAG. THE HANDPIECE WAS REPLACED AND THE CASE CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI MEDTRONIC ADVANCED ENERGY LLC PLASMABLADE 4.0 29403

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PULSAR GENERATOR