BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS

    MDR report key: 1511426 · Received October 7, 2009

    Report

    Report Number
    1511426
    Event Type
    Malfunction
    Date Received
    October 7, 2009
    Date of Event
    October 5, 2009
    Report Date
    October 7, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE STAPLER MISFIRED. DID NOT LAY DOWN THE STAPLES ON THE PROXIMAL END OF THE ANASTOMOSIS.

    Description of Event or Problem · 1

    THE STAPLER MISFIRED. DID NOT LAY DOWN THE STAPLES ON THE PROXIMAL END OF THE ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. CDH29 F4NW7V

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR