BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 221213 · Received April 29, 1999

    Report

    Report Number
    1527736-1999-02544
    Event Type
    Death
    Date Received
    April 29, 1999
    Date of Event
    April 1, 1999
    Manufacturer
    ETHICON ENDO-SURGERY, INC. S.A. DE C.V.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THE PRODUCT WAS USED IN A THORASCOPIC LUNG BIOPSY. IT WAS REPORTED THAT THE SURGEON WAS DISSECTING THORASCOPICALLY BETWEEN LOBES OF THE LUNG AND ENCOUNTERED A 4MM PULMONARY VESSEL. HE CLIPPED IT SEVERAL TIMES AND CUT BETWEEN THE CLIPS. THE VESSEL BEGAN TO HEMORRHAGE AS THE CLIPS CAME OFF THE VESSEL. THIS RESULTED IN DRAMATIC BLOOD LOSS AND THE PT CODED AND HIS HEART STOPPED PUMPING. AFTER A FEW MINUTES OF CPR, THE PT RECOVERED HIS PULSE AND STABILIZED. THE CLIPS WHICH HAD FALLEN OFF THE VESSEL WERE RETRIEVED AND FOUND TO BE GROSSLY MALFORMED. THEY WERE SCISSORED VERSES CLOSED. ALL SIX CLIPS WERE GROSSLY SCISSORED. THE HOSP RETAINED THE CLIP APPLIER AND THE MALFORMED STAPLES FOR FUTURE EVIDENCE. NO MORE ETHICON CLIPS WERE FIRED DURING THE CASE. THE CLIP APPLIER USED DURING THIS CASE WAS THE ER420, 12MM ENDOCLIP APPLIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER CLIP APPLIER GDO ETHICON ENDO-SURGERY, INC. S.A. DE C.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death