BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2822254 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00440
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    October 11, 2011
    Report Date
    October 17, 2011
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 08/15/2010 THROUGH 08/15/2012. VISUAL INSPECTION OF THE RETURNED ADENOID TIP REVEALED THE TIP HAD SLIGHT MELT BACK. THE TIP REMAINED INTACT WITH SLIGHT MELT BACK OF THE CLEAR HOUSING NEAR THE CORNER OF THE ELECTRODE WIRE. THE SLIGHT MELT BACK TO THE HOUSING MAY HAVE BEEN CAUSED BY EXCESSIVE USAGE OF THE TIP AT HIGH POWER SETTING. REVIEW OF THE LOT HISTORY REVEALED NO ANOMALIES. END OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ADENOID TIP HAD WHAT WAS THOUGHT TO BE PLASTIC THAT HAS EITHER MELTED OR PEELED AWAY. IT WAS CLOSE TO THE WIRE, BUT ONLY ON ONE SIDE. THE SCRUB NURSE SAYS IT HAPPENS ON NEARLY EVERY CASE. IT DOESN'T CAUSE ANY IMPACT TO THE PT OR CASE, THE SURGEON DIDN'T EVEN KNOW ABOUT IT UNTIL WE POINTED IT OUT. SECOND OF 2 EVENTS: SEE 3007069406-2012-00439.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI MEDTRONIC ADVANCED ENERGY LLC PLASMABLADE TNA 48125

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PULSAR GENERATOR