BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP

    MDR report key: 1063302 · Received June 19, 2008

    Report

    Report Number
    1219930-2008-00469
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 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: LAPAROSCOPIC RECTOSIGMOID SURGERY. ACCORDING TO THE REPORTER: THREE CLIPS WERE FIRED TO THE ROOT OF INFERIOR MESENTERIC ARTERY. TWO CLIPS WERE APPLIED TO THE NERVE CENTER, AND ONE CLIP WAS APPLIED TO THE DISTAL PART. THE CLIP OF DISTAL PART WAS REMOVED SAFELY WHEN USING ANOTHER INSTRUMENT. THE RECTOSIGMOID SURGERY WAS FINISHED. THEN, THE OPEN HEPATECTOMY WAS STARTED. DURING THE SURGERY, BLOOD PRESSURE INCREASED TO 180 AND DROPPED DOWN TO 30. TWO CLIPS WERE CONFIRMED TO HAVE DISENGAGED FROM THE ROOT OF INFERIOR MESENTERIC ARTERY, AND 1500 CC OF BLEEDING OCCURRED. THE CLIPS WERE RETRIEVED FROM THE CAVITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention