BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLASABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2805577 · Received October 17, 2012

    Report

    Report Number
    3007069406-2012-00236
    Event Type
    Other
    Date Received
    October 17, 2012
    Date of Event
    August 20, 2012
    Report Date
    September 24, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THERE WAS A FLAME WITH THE TNA DEVICE. UNKNOWN IF IT WAS THE TONSIL OR ADENOID TIP. THE PLASMABLADE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A FLAME WITH THE TNA DEVICE. UNKNOWN IF IT WAS THE TONSIL OR ADENOID TIP. NO PATIENT IMPACT REPORTED. (OXYGEN PERCENTAGE WAS 100%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASABLADE TISSUE DISSECTION DEVICE GEI MEDTRONIC ADVANCED ENERGY LLC PLASABLADE TNA 56183

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK