BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP

    MDR report key: 2250034 · Received September 9, 2011

    Report

    Report Number
    1219930-2011-00781
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 25, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDO
    PMA / PMN Number
    K071406
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAP CHOLE. ACCORDING TO THE REPORTER: THE FIRST CLIP LOADED AND SHOT OUT OF THE JAWS IN THE PATIENT, AND THE SECOND CLIP MISFIRED. THE CLIP WAS NOT RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP DISPOSABLE CLIP APPLIER GDO UNITED STATES SURGICAL N1E0711

    Patients

    Seq Age Sex Outcome Treatment
    1 Other