BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2822342 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00405
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K083695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 MFR FOR THE TIME PERIOD (B)(4) 2010 THROUGH (B)(4) 2012. THE DEVICE WAS NOT RETURNED FOR EVAL. REVIEW OF THE LOT HISTORY REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PLASTIC PIECE/SHEATH COVERING THE NON-ACTIVE PART OF BLADE PEELED OFF AFTER SCRUB TECH CLEANED THE BLADE IN THE V-SLOT OF HOLDER. THIS WAS DURING A BILATERAL BREAST REDUCTION. THE SURGEON CONTINUED USING THE BLADE AFTER THE PLASTIC PIECE WAS DISCARDED AND EVERYTHING WENT WELL. THERE WERE NO PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI MEDTRONIC ADVANCED ENERGY LLC PLASMA BLADE 3.0S 45504

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PULSAR GENERATOR