BEUDAMED
    FDA Adverse Event Death Summary report: N

    ETHICON ENDOSURGERY INC.

    MDR report key: 385480 · Received March 26, 2002

    Report

    Report Number
    385480
    Event Type
    Death
    Date Received
    March 26, 2002
    Date of Event
    March 13, 2002
    Report Date
    March 26, 2002
    Manufacturer
    ETHICON ENDOSURGERY INC
    Product Code
    GAG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED TO THE HOSPITAL IN 03/2002. PT WAS TAKEN TO SURGERY THE FOLLOWING DAY FOR LOW ANTERIOR COLON RESECTION WITH END-TO-END ANASTOMOSIS. DIAGNOSIS OF CARCINOMA OF THE RECTOSIGMOID. THE ETHICON 1 PROXIMATE ILS CURVED INTRALUMINAL STAPLER, A STAPLING/CUTTING DEVICE USED AT THE ANASTOMOTIC SITE FAILED. A SECOND ONE WAS USED. PT HAD TO BE TAKEN BACK TO SURGERY 5 DAYS LATER FOR POSSIBLE ANASTOMOTIC LEAK IN THE LOWER SIGMOID COLON WITH PERITONITIS AND POST OPERATIVE WOUND INFECTION. THE SMALL BOWEL WAS NOTED TO BE DISTENDED AND HOLES IN THE COLON. PT EXPIRED IN 2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDOSURGERY INC. 1 PROXIMATE ILS CURVED INTRALUMINAL STAPLER GAG ETHICON ENDOSURGERY INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death| L