BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE

    MDR report key: 2191972 · Received July 28, 2011

    Report

    Report Number
    2191972
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SKIN STAPLER MADE AN UNUSUAL SOUND AND STOPPED CLOSING THE STAPLES ON THE SKIN. STAPLES WERE COMING OUT STRAIGHT, CONFIRMING STAPLER NOT FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE STAPLER, SKIN GDT ETHICON ENDO-SURGERY, INC. PRW35 H43X5H

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR