BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON

    MDR report key: 384628 · Received March 25, 2002

    Report

    Report Number
    384628
    Event Type
    Injury
    Date Received
    March 25, 2002
    Date of Event
    November 15, 2001
    Report Date
    December 17, 2001
    Manufacturer
    C G LABS
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    5MM TROCAR SHEATH BROKE IN HALF DURING PROCEDURE. 2 INCH PIECE HAD TO BE RETRIEVED FROM THE ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON TROCAR GCJ C G LABS 355LD P4N886 OR P4NW0X

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention