BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 45-3.5 DLU

    MDR report key: 2901673 · Received January 2, 2013

    Report

    Report Number
    2647580-2012-00821
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    November 15, 2012
    Report Date
    December 4, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE PT PRESENTED POSTOPERATIVE BLEEDING. NO MORE INFO AVAILABLE. NO PERMANENT DAMAGE. NO TEMPORARY DAMAGE. THE EVENT DID NOT PROLONG THE HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897 ENDO GIA II 45-3.5 DLU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC P1K0224X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other