BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDOSURGERY INC

    MDR report key: 363253 · Received November 21, 2001

    Report

    Report Number
    363253
    Event Type
    Injury
    Date Received
    November 21, 2001
    Date of Event
    October 18, 2001
    Report Date
    November 8, 2001
    Manufacturer
    ETHICON ENDOSURGERY INC
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT TAKEN TO SURGERY FOR EXPLORATORY LAPAROTOMY. PROCEDURES PERFORMED WERE: COLOTOMY, CLOSURE HEMICOLECTOMY AND ILEOTRANSVERSE COLON ANASTOMOSIS. ETHICON TCR 55 LINEAR CUTTER RELOAD WAS USED DURING PROCEDURE. PT RETURNED TO SURGERY 11 DAYS LATER FOR POST RIGHT HEMICOLECTOMY WITH DISRUPTION OF ANASTOMOSIS, PERITONITIS AND ENTEROCUTANEOUS FISTULA. POST OPERATIVE STATUS: WOUND INFECTION WITH SEPSIS. PT TOLERATED PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53099 ETHICON ENDOSURGERY INC 1 PROXIMATE LINEAR CUTTER RELOAD GAG ETHICON ENDOSURGERY INC TCR55 *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention