BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE

    MDR report key: 3200857 · Received May 31, 2013

    Report

    Report Number
    3200857
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ID, US

    Narratives

    Description of Event or Problem · 1

    A CERTIFIED SCRUB TECH WAS RELOADING THE LINEAR CUTTER DURING A PROCEDURE. THE STAPLER DISCHARGED AND FIRED STAPLE INTO THE EMPLOYEE'S LEFT FINGER.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NADEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241930 PROXIMATE STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, INC. TCT75 K4C84T

    Patients

    Seq Age Sex Outcome Treatment
    1 *