BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 45-2.5 DLU

    MDR report key: 555157 · Received November 15, 2004

    Report

    Report Number
    1219930-2004-00354
    Event Type
    Injury
    Date Received
    November 15, 2004
    Date of Event
    September 17, 2004
    Report Date
    October 18, 2004
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE PT HAD AN LAVH AND EXCISION OF ENDOMETRIOSIS PERFORMED IN 2003 WITH AN ENDO GIA UNIVERSAL (030449) STAPLER AND 3 ENDO GIA II 45-2.5 SULUS (030425). HOWEVER, IN 2004 A FOREIGN BODY (SMALL PIECE OF METAL) HAD TO BE REMOVED FROM THE PT. PROCEDURE: LAVH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA II 45-2.5 DLU DISPOSABLE SURGICAL STAPLER GCJ NORTH HAVEN - USS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R