BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLASMABLADE TNA TISSUE DISSECTION DEVICE

    MDR report key: 1943520 · Received December 2, 2010

    Report

    Report Number
    3007069406-2010-00015
    Event Type
    Other
    Date Received
    December 2, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 3, 2010
    Manufacturer
    PEAK SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT RETAIN THE DEVICE AND DID NOT PROVIDE A LOT NUMBER FOR THE TNA DEVICE. THEREFORE, AN INVESTIGATION OF THE LOT HISTORY FILE OF THE DEVICE CANNOT BE CONDUCTED. PT #1: RETURNED TO HOSPITAL 6 DAYS POST OPERATIVELY FOLLOWING A TONSILLECTOMY AND ADENOIDECTOMY WITH BLEEDING FROM ADENOID FOSSA. BLEEDING CHARACTERIZED AS MINOR AND CAUTERIZED WITH SILVER NITRATE VIA A COTTON APPLICATOR IN THE ED. ADD'L F/U AT THREE WEEKS POST-BLEEDING WAS UNREMARKABLE. PHYSICIAN STATED THAT A COMBINATION OF TECHNIQUE AND PT'S DIFFICULT ANATOMY WAS LIKELY SOURCE OF ADVERSE EVENT AND NOT THE PLASMABLADE. END OF REPORT. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    POST-OP BLEEDING OCCURRED ON TWO (2) ADULT PTS FOLLOWING A TONSILLECTOMY AND ADENOIDECTOMY. THIS REPORT IS FOR PT #1.

    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 Other NOT AVAILABLE