BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEAK PLASMA BLADE 4.0

    MDR report key: 2771838 · Received October 1, 2012

    Report

    Report Number
    MW5027149
    Event Type
    Injury
    Date Received
    October 1, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 24, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE GENERATOR ERASED WHEN PEAK PLASMA BLADE WAS PLUGGED IN; THIS INDICATED THAT THE BLADE WAS NOT FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEAK PLASMA BLADE 4.0 ELECTROSURGICAL DEVICE GEI MEDTRONIC ADVANCED ENERGY LLC 54502

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention