BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON

    MDR report key: 2132711 · Received June 10, 2011

    Report

    Report Number
    MW5021008
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ETHICON J & J
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE, TROCAR SHEATH #355 BROKE. TWO LARGE PIECES BROKE AT HUB AND BEGINNING OF TROCAR SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON #5 TROCAR SHEATH GCJ ETHICON J & J 355

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR