BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2295392 · Received September 21, 2011

    Report

    Report Number
    2295392
    Event Type
    Malfunction
    Date Received
    September 21, 2011
    Date of Event
    September 8, 2011
    Report Date
    September 16, 2011
    Manufacturer
    LEICA MICROSYSTEMS, INC.
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    THE LEICA OH5 MICROSCOPE WAS IN OR AND PLUGGED INTO THE EXTENSION CORD. IT WAS TURNED ON, BALANCED, AND READY TO USE FOR THE OPERATION. THE TRUVISION WAS ATTACHED AND NO PROBLEMS WERE NOTICED. THE CASE WAS BEING STARTED WHEN A FOUL ODOR WAS NOTICED IN THE OR. SUDDENLY SMOKE WAS SEEN RUSHING OUT OF THE BACK AND SIDE OF THE MICROSCOPE. THE MICROSCOPE WAS QUICKLY TURNED OFF AND UNPLUGGED. THE OR WAS VISIBLY SMOKEY AND THE FOUL ODOR WAS NOTICED FOR OVER AN HOUR AFTER THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * MICROSCOPE, SURGICAL EPT LEICA MICROSYSTEMS, INC. OH5 *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR