BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPMI GCFC CEILING MOUNTED EYE

    MDR report key: 32486 · Received April 30, 1996

    Report

    Report Number
    32486
    Event Type
    Malfunction
    Date Received
    April 30, 1996
    Date of Event
    April 15, 1996
    Report Date
    April 17, 1996
    Manufacturer
    CARL ZEISS, INC.
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EYE MICROSCOPE MALFUNCTIONED DURING CATARACT CASE, ELECTRICAL PROBLEM IN EQUIPMENT (FUSE). PT NEEDS TO HAVE A RETURN TO SURGERY AT A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPMI GCFC CEILING MOUNTED EYE CEILING MOUNTED EYE EPT CARL ZEISS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other