BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA 2.5MM

    MDR report key: 2061831 · Received April 13, 2011

    Report

    Report Number
    MW5020289
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 13, 2011
    Manufacturer
    AUTO SUTURE US SURGICAL
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC APPENDECTOMY, WE USED A MULTI FIRE ENDO GIA THAT MALFUNCTIONED 1ST BY NOT FIRING, SECONDLY BY NOT RELEASING (#(B)(4) AUTO SUTURE ENDO GIA 30 2.5MM LOT #POM0959). WE OPENED A NEW STAPLER AND USED IT. NO INJURY TO PT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA 2.5MM AUTO SUTURE GDW AUTO SUTURE US SURGICAL POM0959

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability