BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YELLO PORT

    MDR report key: 3042693 · Received April 3, 2013

    Report

    Report Number
    MW5029643
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 3, 2013
    Manufacturer
    CLAYTON WOOD HOUSE, SURGICAL INOVATIONS
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC SURGERY, A SEAL FROM A TROCAR, BEING USED, WAS RETRIEVED FROM THE PT'S ABDOMEN. THE FOREIGN BODY WAS DISCOVERED AND RETRIEVED. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136911 YELLO PORT TROCAR GCJ CLAYTON WOOD HOUSE, SURGICAL INOVATIONS 66514

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR