BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3763207 · Received April 3, 2014

    Report

    Report Number
    3763207
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 17, 2014
    Report Date
    April 3, 2014
    Manufacturer
    LEICA BIOSYSTEMS IMAGING, INC
    Product Code
    NOT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SCOPE WOULD NOT FOCUS. PATIENT WAS ON THE TABLE, EXPOSED, THE SURGICAL TEAM WAS READY FOR THE SCOPE AND IT WOULD NOT FOCUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200668 * MICROSCOPE NOT LEICA BIOSYSTEMS IMAGING, INC OHS-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR