BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL

    MDR report key: 4131212 · Received September 22, 2014

    Report

    Report Number
    4131212
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    September 14, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, INC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON PUT A TROCAR IN THIS PATIENT AND WHEN HE PASSED THE INSTRUMENT (GRASPER) THROUGH THE TROCAR, A PIECE OF RUBBER FROM THE TROCAR FELL INTO THE BELLY OF THE PT. SURGEON PICKED UP AND REMOVED THE RUBBER PIECE. HE INSPECTED THE PATIENT FOR ANY OTHER FOREIGN OBJECTS WHICH HE FOUND NONE. STAFF REMOVED ALL THE COMPONENTS OF THIS TROCAR FROM THE FIELD AND SEALED THEM IN A BIOHAZARD BAG FOR SEQUESTERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588110 ENDOPATH XCEL TROCAR GCJ ETHICON ENDO-SURGERY, INC * L4EW9V

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR