BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1151473 · Received September 5, 2008

    Report

    Report Number
    1219930-2008-00666
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 5, 2008
    Report Date
    September 2, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: VATS. ACCORDING TO THE REPORTER: STAPLES ARE DEFORMED AND THERE WAS A PROBLEM TO OPEN THE E-GIA INSTRUMENT. THE MALFORMED STAPLE LINE WAS RESECTED TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE STAPLING DEVICE GDW NORTH HAVEN - USS N8E99

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability MANUFACTURE DATE: 03/01/2008| EXP. DATE: 03/31/2013| 030458| LOT N8C98