BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP

    MDR report key: 1081232 · Received July 23, 2008

    Report

    Report Number
    1219930-2008-00546
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 16, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDO
    PMA / PMN Number
    K071406
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: LAP COLON. ACCORDING TO THE REPORTER: THE SURGEON CONFIRMED THAT THE FOURTH LOADING WAS SUCCESSFUL. THEN HE SQUEEZED THE HANDLE, BUT THE CLIP DID NOT COME OUT. UPON LOADING WITH THE NEXT CLIP, A FORMED CLIP DROPPED OUT OF JAWS INTO THE PATIENT CAVITY. THE SURGEON CONSIDERED THAT WOULD HAVE NO ILL EFFECT ON PATIENT BECAUSE THE CLIP WAS FORMED, SO THE SURGEON LEFT THE CLIP INSIDE THE CAVITY. HE CONTINUED TO USE THIS ENDO CLIP AND THEN TWO FIRES WERE SUCCESSFUL. THE PROCEDURE WAS COMPLETED. NO TISSUE DAMAGE. NO BLEEDING. PATIENT STATUS REPORTED AS OK.

    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 U8E102

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other