BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 60-3.5 SULU

    MDR report key: 1780802 · Received July 27, 2010

    Report

    Report Number
    1219930-2010-00583
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 22, 2010
    Manufacturer
    UNITED STATES SURGICAL
    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).

    Description of Event or Problem · 1

    PROCEDURE: LOBECTOMY. ACCORDING TO THE REPORTER: AFTER THE 4TH FIRING, THE BLACK RETURN KNOB WAS RETURNED, BUT THE JAWS WOULD NOT OPEN. ADD'L RESECTION OF TISSUE WAS DONE TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 60-3.5 SULU DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N9F0095

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability (B)(4), LOT #: N0C0460| EXP DATE: 3/31/15, MANUFACTURE DATE: 3/2010| GIA UNIVERSAL