BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2822292 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00176
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    March 7, 2012
    Report Date
    May 11, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 REVEALED THE ELECTRODE WIRE WAS BROKEN. THE WIRE BROKE FROM THE RIGHT CORNER OF THE HOUSING AND THEN THE HOUSING MELTED BACK. USER CLEANING TECHNIQUE MAY HAVE CONTRIBUTED TO THE BREAKAGE. THE HOUSING MELT BACK MAY HAVE BEEN CAUSED BY EXCESSIVE USAGE OF THE TIP AT A HIGH POWER SETTING. REVIEW OF THE LOT HISTORY WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNK. END OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PEAK DEVICE WIRE BROKE. THE TIP BROKE DURING THE CLEANING PROCESS IN BETWEEN THE CUTTING PROCEDURE. THERE WERE NO PT CONSEQUENCES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PULSAR GENERATOR