BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2822308 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00436
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    September 16, 2011
    Report Date
    September 19, 2011
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 ADENOID TIP REVEALED THE ELECTRODE WIRE WAS BROKEN AND THE CLEAR HOUSING NEAR THE CORNER OF THE ELECTRODE WIRE. REVIEW OF THE LOT HISTORY REVEALED NO ANOMALIES. END OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TIP SHOWED SIGNS OF MELTING. THERE WAS NO PT IMPACT. FIRST OF 2 PTS: SEE 3007069406-2012-00435.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI MEDTRONIC ADVANCED ENERGY LLC PLASMABLADE TNA 47833

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PULSAR GENERATOR