BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA OH 5 IC GREEN

    MDR report key: 2875259 · Received November 24, 2012

    Report

    Report Number
    2875259
    Event Type
    Malfunction
    Date Received
    November 24, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 25, 2012
    Manufacturer
    LEICA MICROSYSTEMS, INC.
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN IC GREEN MODE WAS SELECTED, AN ERROR WAS REPORTED ON THE SYSTEM WHICH REQUIRED THE MICROSCOPE TO BE TURNED OFF AND RESTARTED. DR STATED THAT THE LEICA COMPANY KNOWS ABOUT THE GLITCH IN THE COMPUTER PROGRAM AND HAS BEEN HERE PREVIOUSLY TO FIX THE PROGRAM. THIS WAS A LEICA MICROSCOPE OH 5 IC GREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEICA OH 5 IC GREEN MICROSCOPE, SURGICAL EPT LEICA MICROSYSTEMS, INC. OH5 *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR