BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMA BLADE TISSUE DISSECTION DEVICE

    MDR report key: 2822343 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00404
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    March 23, 2011
    Report Date
    March 30, 2011
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. VISUAL INSPECTION OF THE RETURNED DEVICE NOTED THE ELECTRODE BLADE WAS LOOSE FROM THE BENDABLE SHAFT. THE ELECTRODE CUTTING EDGE MAY HAVE UNDERGONE EXCESSIVE LATERAL FORCE APPLICATION DURING USE. THE LATERAL FORCE MAY HAVE ATTRIBUTED TO THE BLADE COMING LOOSE AT THE WELD JOINT BETWEEN THE BENDABLE SHAFT AND THE ELECTRODE BLADE. THE DISTAL INSULATION THAT SPLIT/PEELED BACK ON THE BENDABLE SHAFT WOULD HAVE INDICATED THAT THE DEVICE MAY HAVE BEEN AGGRESSIVELY USED. REVIEW OF THE LOT HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS NOT PROVIDED. END OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A CASE, THE BLADE FRAYED. THERE WERE NO PT CONSEQUENCES. SECOND OF 2 EVENTS; SEE 3007069406-2012-00403.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMA BLADE TISSUE DISSECTION DEVICE GEI MEDTRONIC ADVANCED ENERGY LLC PLASMABLADE 4.0 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PULSAR GENERATOR