BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2467808 · Received February 21, 2012

    Report

    Report Number
    3007069406-2012-00034
    Event Type
    Other
    Date Received
    February 21, 2012
    Date of Event
    February 3, 2012
    Report Date
    February 3, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, THE PRODUCT HAD NOT BEEN RECEIVED FROM INVESTIGATION. A CORRECTIVE ACTION REPORT HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS TYPE OF FAILURE MODE ((B)(4)).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TONSIL TIP CAUGHT FIRE. 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 51855

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NOT AVAILABLE