BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLASMABLADE TNA TISSUE DISSECTION DEVICE

    MDR report key: 1961647 · Received January 10, 2011

    Report

    Report Number
    3007069406-2011-00002
    Event Type
    Other
    Date Received
    January 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    PEAK SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT RETAIN THE DEVICE AND DID NOT PROVIDE A LOT NUMBER; THEREFORE, AN INVESTIGATION OF THE DEVICE OR THE LOT HISTORY RECORD COULD NOT BE PERFORMED. ADENOID TIP CAME OFF DURING ADENOIDECTOMY BUT WAS RE-SEATED TO COMPLETE THE PROCEDURE. FOLLOWING COMPLETION OF SURGERY, PHYSICIAN NOTICED RING-SHAPED, 1ST DEGREE BURN ON SKIN OF LEFT CHEEK WHICH MAY HAVE OCCURRED WHEN TIP FELL OFF. ANTIBIOTIC OINTMENT WAS APPLIED TO BURN. AT POST-OP F/U VISIT, BURN HAD HEALED NORMALLY. IF ADDITIONAL INFO BECOMES AVAILABLE, THE MFR WILL FILE A F/U REPORT.

    Description of Event or Problem · 1

    PT EXPERIENCED SMALL BURN ON CHEEK DURING ADENOIDECTOMY WHEN ADENOID TIP CAME OFF HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TNA TISSUE DISSECTION DEVICE GEI PEAK SURGICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other NOT AVAILABLE