BEUDAMED
    FDA Adverse Event Death Summary report: N

    PREMIUM SURGICLIP M-11.5 TITANIUM

    MDR report key: 518502 · Received March 30, 2004

    Report

    Report Number
    2647580-2004-00060
    Event Type
    Death
    Date Received
    March 30, 2004
    Date of Event
    February 25, 2004
    Report Date
    February 27, 2004
    Manufacturer
    PONCE - USS
    Product Code
    GAG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THIS CASE STARTED AS A LAP CHOLE AND WAS CONVERTED TO AN OPEN PROCEDURE FOR REASONS UNKNOWN. THE PT EXPIRED IN RECOVERY. ACCORDING TO THE INFO THE SALES REP RECEIVED, THE AUTOPSY SHOWED THAT THERE WERE NO CLIPS ON THE CYSTIC ARTERY. THE SURGEON INFORMED THE CO OF AN INCIDENT INVOLVING A CHOLECYSTECTOMY PT IN WHICH HE FEELS THERE WAS A FAILURE OF THIS PRODUCT. THIS FAILURE CONTRIBUTED TO THE DEATH OF HIS PT IN 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM SURGICLIP M-11.5 TITANIUM DISPOSABLE CLIP APPLIER GAG PONCE - USS NA P3C475

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death