BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP

    MDR report key: 1192768 · Received October 8, 2008

    Report

    Report Number
    1219930-2008-00735
    Event Type
    Injury
    Date Received
    October 8, 2008
    Date of Event
    August 19, 2008
    Report Date
    September 22, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDO
    PMA / PMN Number
    K071406
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP CHOLE. ACCORDING TO THE REPORTER: THE JAWS LOCKED DOWN ON TISSUE AND SURGEON CUT THE TISSUE TO REMOVE THE DEVICE FROM THE PT. NO DELAY TO OPERATING TIME AND NO SIGNIFICANT BLEEDING OCCURRED AS A RESULT. A NEW INSTRUMENT OF DIFFERENT TYPE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP DISPOSABLE CLIP APPLIER GDO NORTH HAVEN - USS U8E121

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention