BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTO SUTURE PREMIUM CEEA

    MDR report key: 37822 · Received September 6, 1996

    Report

    Report Number
    1219161-1996-00034
    Event Type
    Death
    Date Received
    September 6, 1996
    Date of Event
    April 22, 1996
    Report Date
    September 6, 1996
    Manufacturer
    UNITED STATES SURGICAL CORP
    Product Code
    GAG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS USED DURING A LOW ANTERIOR RESECTION PROCEDURE. REPORTEDLY, THE ANASTOMOSIS WAS INTACT WHEN INSPECTED AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. REPORTEDLY, THE PT WAS RE-ADMITTED TEN DAYS POST-OPERATIVELY DISPLAYING PERITONITIS. THE PT EXPIRED ONE DAY AFTER RE-ADMITTANCE DUE TO MULTIPLE SYSTEMS ORGAN FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE PREMIUM CEEA DISPOSABLE STAPLER GAG UNITED STATES SURGICAL CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death