BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP

    MDR report key: 47887 · Received September 30, 1996

    Report

    Report Number
    47887
    Event Type
    Injury
    Date Received
    September 30, 1996
    Date of Event
    September 27, 1996
    Report Date
    September 30, 1996
    Manufacturer
    ETHICON, ENDO-SURG, INC.
    Product Code
    DSS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ABOUT 10PM PT BECAME INCREASINGLY DIAPHORETIC, CLAMMY, BP 70/50, VERY PALE, UNRESPONSIVE. RECEIVED A BOLUS OF IV FLUIDS, RECEIVED 7 UNITS OF BLOOD AND PLASMA. PT RETURNED TO OR. FOUND ARTERIAL CLIPS FREE IN ABDOMINAL CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP Implant ENDOSCOPIC ROTATING MULTIPLE CLIP APPLICATOR DSS ETHICON, ENDO-SURG, INC. ER320 343F3P

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| O