BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON

    MDR report key: 2132692 · Received June 10, 2011

    Report

    Report Number
    MW5021009
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    April 28, 2011
    Report Date
    June 7, 2011
    Manufacturer
    J & J ETHICON
    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

    INSERTING 5MM TROCAR - TROCAR PORTION OF THE SHEATH BROKE FROM HUB - 2 LARGE PIECES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR