BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE

    MDR report key: 1945414 · Received December 22, 2010

    Report

    Report Number
    1945414
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAPLER WOULD NOT FIRE. NO PATIENT HARM, OPENED NEW ONE TO FINISH CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. TX60B G4U459

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR