BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2625773 · Received June 13, 2012

    Report

    Report Number
    3007069406-2012-00105
    Event Type
    Other
    Date Received
    June 13, 2012
    Date of Event
    May 11, 2012
    Report Date
    May 15, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A TONSIL TIP IGNITION WAS REPORTED TO THE MANUFACTURER. NO PT IMPACT. THE PLASMABLADE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE GENERATOR, PULSAR II, SN (B)(4), WAS ALSO BEING RETURNED FOR EVALUATION. ONCE THE INVESTIGATIONS HAVE BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TONSIL TIP IGNITED. NO PT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI MEDTRONIC ADVANCED ENERGY LLC PLASMABLADE TNA 54354

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NOT AVAILABLE