BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIL OPTICAL ACCESS SYSTEM

    MDR report key: 2081826 · Received May 3, 2011

    Report

    Report Number
    MW5020507
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 3, 2011
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TROCAR WAS BEING USED FOR ABOUT AN HOUR IN DAVINCI MIDCAB FOR DAVINCI 30 DEGREE LENS. DURING THE CASE, THE TROCAR BECAME FRACTURED, AND A PIECE OF PLASTIC WAS RETAINED BY PT. THE SURGEON PERFORMED VATS EXPLORATION AND WAS ABLE TO RETRIEVE THE RETAINED PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIL OPTICAL ACCESS SYSTEM TROCAR 12 X 150 MM GCJ APPLIED MEDICAL 1127402

    Patients

    Seq Age Sex Outcome Treatment
    1