BEUDAMED
    FDA Adverse Event Other Summary report: N

    ETHICON ENDO-SURGERY, INC.

    MDR report key: 564433 · Received November 24, 2004

    Report

    Report Number
    MW1034146
    Event Type
    Other
    Date Received
    November 24, 2004
    Date of Event
    November 10, 2004
    Report Date
    November 23, 2004
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ACTIVATION OF LAP STAPLING DEVICE, THE STAPLE LOAD FELL OFF IN THE DEVICE, THIS CAUSED THE PT TO INCUR BLEEDING WHICH WAS SUBSEQUENTLY CONTROLLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, INC. ENDOSCOPIC ARTICULATING LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. ATW45-REF V42R66

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other