BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTIFIRE ENDO GIA 30

    MDR report key: 34624 · Received July 17, 1996

    Report

    Report Number
    34624
    Event Type
    Death
    Date Received
    July 17, 1996
    Date of Event
    May 21, 1996
    Report Date
    July 15, 1996
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FAILURE OF STAPLES TO CLOSE DURING SURGICAL PROCEDURE RESULTING IN PERITONITIS. 5/21: PT UNDERWENT CLOSURE OF GASTRIC FISTULA AND ENTERAL FEEDINGS BEGUN POST-OP. 5/22: PT C/O PAIN, RETURNED TO SURGERY, FEEDING SUBSTANCE NOTED IN PERITONEUM. SURGEON STATED HE FOUND "SEVERAL" STAPLES HAD NOT CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIFIRE ENDO GIA 30 ENDO STAPLER GAG UNITED STATES SURGICAL CORP. 30-3.5 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death