BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLASMABLADE TNA TISSUE DISSECTION DEVICE

    MDR report key: 1943597 · Received December 9, 2010

    Report

    Report Number
    3007069406-2010-00018
    Event Type
    Other
    Date Received
    December 9, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    PEAK SURGICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SALES REP RETAINED THE DEVICE BUT HAS NOT YET RETURNED IT TO PEAK SURGICAL. THE INVESTIGATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE. ACCORDING TO THE PHYSICIAN, THE BURN OCCURRED DURING AN ADENOIDECTOMY AT THE RIGHT ORAL COMMISSURE. IT WAS DETERMINED THAT THE ADENOID TIP CAME OFF THE HANDPIECE SHAFT EXPOSING THE METAL-SHAFT CONNECTION. DUE TO THE SIZE OF THE PT, THIS JUNCTION WAS IN DIRECT CONTACT WITH THE ORAL COMMISSURE DURING THIS PORTION OF THE PROCEDURE. THE PHYSICIAN COULD NOT RECALL THE CONNECTION/FIT OF THE ADENOID TIP TO THE HANDPIECE SHAFT HAD BEEN CHECKED PRIOR TO USE. THE BURN WAS DESCRIBED AS A "MINOR, 1ST DEGREE BURN" THAT WAS "RED". IT WAS TREATED WITH ANTIBIOTIC OINTMENT AND THE PHYSICIAN FELT IT WOULD HEAL WITHOUT FURTHER TREATMENT. THE PT WAS EVALUATED IN CLINIC SEVEN DAYS AFTER SURGERY AND THE BURN WAS NOTED TO BE "WELL HEALED".

    Description of Event or Problem · 1

    ADENOID TIP CAME OFF DURING THE CASE AND BURNED THE MOUTH OF THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other NOT AVAILABLE