BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE

    MDR report key: 1981910 · Received January 27, 2011

    Report

    Report Number
    1981910
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 27, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    DEVICE FIRED AND CUT CORRECTLY BUT THE STAPLES DID NOT CLOSE THE CENTER OF THE BOWEL, SECOND STAPLER OPENED AND WORKED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. TLC75 G4UE25

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR