BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 2112349 · Received May 25, 2011

    Report

    Report Number
    1219930-2011-00442
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 19, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LIVER RESECTION. ACCORDING TO THE RPTR: WHEN THE INSTRUMENT WAS APPLIED TO THE HEPATIC VEIN, IT JAMMED WITH THE KNIFE BLADE IN COMPLETE EXTENSION. IT WAS NOT POSSIBLE TO RE-OPEN THE INSTRUMENT. THE DEVICE WAS PRIED OFF THE VEIN WITH ANOTHER INSTRUMENT. THE EVENT DID NOT RESULT IN UNANTICIPATED BLOOD LOSS OF MORE THAN 250CC. THERE WAS NO UNANTICIPATED TISSUE DAMAGE OR RESECTION AS A RESULT OF THIS EVENT. OPERATING ROOM TIME HAD TO BE EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE SURGICAL STAPLING DEVICE GDW UNITED STATES SURGICAL N0K0203

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CATALOG # 030454, LOT # N0C0413.| ENDO GIA ROTICULATOR 45-2.5 SULU:| EXPIRATION DATE: 03/31/2015.