BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 45-3.5 DLU

    MDR report key: 1003848 · Received February 14, 2008

    Report

    Report Number
    1219930-2008-00132
    Event Type
    Injury
    Date Received
    February 14, 2008
    Date of Event
    November 19, 2007
    Report Date
    January 18, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAG
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: UNK. ACCORDING TO THE USER FACILITY REPORT: SURGEON REPORTED THAT ON THE FOLLOW-UP VISIT PIECE OF BLADE AND LOCKING MECHANISM FROM STAPLER NOTED ON CHEST X-RAY. DETERMINED MORE RISKY TO REMOVE THAN LEAVE IN PLACE, PIECE IS 1CM X 7MM X 2MM. THE PRODUCT IS NOT AVAILABLE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA II 45-3.5 DLU DISPOSABLE SURGICAL STAPLER GAG NORTH HAVEN - USS * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other