BEUDAMED
    FDA Adverse Event Death Summary report: N

    ETHICON

    MDR report key: 572688 · Received February 11, 2005

    Report

    Report Number
    572688
    Event Type
    Death
    Date Received
    February 11, 2005
    Date of Event
    January 13, 2005
    Report Date
    February 10, 2005
    Manufacturer
    JOHNSON AND JOHNSON
    Product Code
    DSS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2005 PT UNDERWENT A LAPAROSCOPIC CHOLESTERTECTOMY AT 0700. PT BECAME HYPOTENSIVE AROUND 1100. WAS TAKEN BACK TO THE OR FOR ANOTHER LAP CHOLE BUT WAS CONVERTED TO AN OPEN AFTER BLOOD WAS FOUND (SMALL AMT) IN THE UPPER ABDOMEN. THE AREA OF BLEEDING WAS IN THE AREA OF THE POSTERIOR CYSTIC ARTERY BRANCH, THE CLIP HAD FALLEN OFF. PT RECEIVED 3 UNITS OF BLOOD. PT RETURNED TO SURGERY AGAIN AT 1855 FOR BLEEDING DIATHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO CLIP APPLIER DSS JOHNSON AND JOHNSON EL 314 R-9608P

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death