BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 45-3.5 DLU

    MDR report key: 1954602 · Received December 6, 2010

    Report

    Report Number
    1219930-2010-00921
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    August 23, 2010
    Report Date
    November 29, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: A 1.0 X 0.5 CM RECTANGULAR METALLIC FOREIGN BODY, POSSIBLY WITHIN THE RIGHT POSTERIOR PLEURAL SPACE HAS BEEN PRESENT SINCE THE PT'S SURGERY. THIS SURGERY WAS DONE ON (B)(6) 2009, BUT THE OBJECT WAS SEEN ON A CT SCAN IN (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA II 45-3.5 DLU DISPOSABLE STAPLER GDW UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other