BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDW

    MDR report key: 971225 · Received March 9, 2007

    Report

    Report Number
    1527736-2007-01510
    Event Type
    Malfunction
    Date Received
    March 9, 2007
    Report Date
    February 20, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. ADDITIONAL INFO REC'D: SURGEON ADVISED THAT THE STAPLE CARTRIDGE FELL OUT WHEN USING IT. BLEEDING WAS NOT A RESULT OF THE CARTRIDGE FALING OUT. THE PT HAD TO BE OPENED DUE TO HER CANCEROUS LUNG THAT WAS NECROTIC CAUSED THE BLEEDING. BECAUSE VISUALATIZATION WAS COMPROMISED DUE TO THE BLEEDING, THE CONVERT TO OPEN WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDW GDW ETHICON ENDO SURGERY, INC (CINCINNATI)

    Patients

    Seq Age Sex Outcome Treatment
    1