BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE

    MDR report key: 1913123 · Received November 23, 2010

    Report

    Report Number
    1913123
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEVICE FAILED TO FIRE STAPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. TL60 G4TN3P

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR NO OTHER THERAPIES