BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLASMABLADE TNA TISSUE DISSECTION DEVICE

    MDR report key: 2001349 · Received February 18, 2011

    Report

    Report Number
    3007069406-2011-00005
    Event Type
    Other
    Date Received
    February 18, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 25, 2011
    Manufacturer
    PEAK SURGICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY RETURNED THE DEVICE BUT THE CORD WAS SEVERED, SO AN INVESTIGATION OF THE LOT HISTORY RECORD COULD NOT BE PERFORMED. HOWEVER, A VISUAL INSPECTION AND PHYSICAL ASSESSMENT WILL BE PERFORMED. THE MANUFACTURER IS ATTEMPTING TO CONTACT THE PHYSICIAN FOR ADDITIONAL DETAILS ABOUT THE INCIDENT. WHEN ADDITIONAL INFORMATION ABOUT THE INCIDENT BECOMES AVAILABLE AND THE COMPLAINT INVESTIGATION REPORT IS COMPLETED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    TIP ON ADENOID DEVICE DISLODGED DURING ADENOIDECTOMY AND FELL INSIDE PATIENT'S MOUTH. THERE WAS A SLIGHT WHITE BLANCHED BURN MARK INSIDE PATIENT'S CHEEK THAT DID NOT REQUIRE ADDITIONAL TREATMENT.

    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 UNK Other