BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIR UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1610726 · Received February 10, 2010

    Report

    Report Number
    1219930-2010-00077
    Event Type
    Injury
    Date Received
    February 10, 2010
    Date of Event
    February 4, 2010
    Report Date
    February 4, 2010
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4).

    Description of Event or Problem · 1

    PROCEDURE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: TISSUE MIGHT BE THICK, SO PART OF THE CARTRIDGE WAS BROKEN. THE SULU FIRED, BUT ADD'L RESECTION OF TISSUE WAS NEEDED TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIR UNIVERSAL 12MM SINGLE USE INST DISPOSABLE STAPLER GDW NORTH HAVEN - USS N9B156

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability LOT NUMBER: N9G0087, EXPIRATION DATE: 08/31/2014| 030459, ENDO GIA ROTICULAR 60-4.8 SULU| MANFACTURE DATE: 08/2009