BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TISSUE DISSECITON DEVICE

    MDR report key: 2821265 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00459
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Report Date
    April 20, 2010
    Manufacturer
    MEDTORNIC 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 AS A RESULT OF A RETROSPECTIVE REVIEW OF MARKETING EVALUATIONS RECEIVED BY THE MANUFACTURER. THE PLASMABLADE USED IN THE REPORTED COMPLAINT WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE LOT HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED FORM A CUSTOMER EVALUATION (USED ON A TOTAL HIP AND AN ABOVE THE KNEE AMPUTATION), THE COAG WAS UP TO 10 AND THEY STILL NEEDED BETTER CONTROL; THE DEVICE NEEDED TO COAG BETTER. ALSO THE GRAY TIP JUST COMES OFF. THE SURGEON ALSO COMMENTED HE WOULD LIKE THE TIP TO BE STIFFER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PULSAR GENERATOR SERIAL NUMBER (B)(4)