BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 3161991 · Received May 29, 2013

    Report

    Report Number
    1219930-2013-00394
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 3, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE INSTRUMENT CLOSED OVER THE STRUCTURE PROPERLY, BUT BLOCKED DURING FIRING AND WOULD NOT OPEN AND WAS UNABLE TO BE REMOVED FROM THE TISSUE. WITH A SECOND INSTRUMENT, IT WAS SET DISTAL AGAIN AND THE FIRST INSTRUMENT WAS ABLE TO BE REMOVED FROM THE TISSUE. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO REINFORCEMENT MATERIAL USED IN CONJUNCTION WITH THE STAPLING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234368 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL N2H0148X

    Patients

    Seq Age Sex Outcome Treatment
    1