BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDOSURGERY INC.

    MDR report key: 334777 · Received May 23, 2001

    Report

    Report Number
    334777
    Event Type
    Injury
    Date Received
    May 23, 2001
    Date of Event
    May 8, 2001
    Report Date
    May 23, 2001
    Manufacturer
    ETHICON ENDOSURGERY, INC.
    Product Code
    GAG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FAILURE OF STAPLING DEVICE RESULTING IN ANASTAMOTIC LEAK AT PROXIMAL ILEUM. THIS RESULTED IN ACUTE ABDOMEN AND REPEAT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23968 ETHICON ENDOSURGERY INC. 1 PROXIMATE RELOADABLE LINEAR STAPLER GAG ETHICON ENDOSURGERY, INC. (REF) TLH90 *

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization| L| R