BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2821245 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00485
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Report Date
    June 2, 2012
    Manufacturer
    MEDTORNIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K083695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 REVEALED NO ANOMALIES. END OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED AS PART OF A MARKET EVALUATION, THE GREY FINER GRIP HAD SOME DEGRADATION/MELTING. ALSO, 2 OF BLADES DID NOT WORK; IT MAY HAVE BEEN A PT GROUNDING ISSUE. THE MARKET EVALUATION FORM INDICATES 2 DIFFERENT DAYS; BUT IT IS UNCERTAIN WHAT HAPPENED ON WHAT DAY; THEREFORE, ONE REPORT IS BEING SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI MEDTORNIC ADVANCED ENERGY LLC PLASMABLADE 3.0S 28779

    Patients

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