BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2822346 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00400
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Report Date
    March 23, 2011
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K083695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MFR FOR THE TIME PERIOD (B)(4) 2012. FAILURE INVESTIGATION OF THE RETURNED DEVICE FOUND THE DEVICE WAS NOT PROGRAMMED. THE ERROR CODE OF E7; DEVICE NOT RECOGNIZED BY GENERATOR WAS DISPLAYED. THE FAILURE MAY HAVE BEEN THAT THE DEVICE WAS MISPLACED INTO THE PROGRAMMED DEVICE BIN DURING THE MFG STEP AND WAS PACKAGED WITHOUT KNOWING THAT THE DEVICE WAS NOT PROGRAMMED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A MASTECTOMY CASE, THE HAND PIECE STOPPED WORKING, AN AUDIBLE ALARM WAS HEARD AND AN ERROR CODE WAS DISPLAYED ON THE SCREEN. A NEW ONE WAS OPENED AND THE CASE CONTINUED. THERE WERE NO PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI MEDTRONIC ADVANCED ENERGY LLC PLASMABLADE 3.0S UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PULSAR GENERATOR