BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPMI LUMERA 700

    MDR report key: 3377275 · Received August 11, 2013

    Report

    Report Number
    3377275
    Event Type
    Malfunction
    Date Received
    August 11, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 9, 2013
    Manufacturer
    CARL ZEISS, INC.
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT IN THE OPERATING ROOM, GETTING READY TO DO THE CASE; RESIDENT PREPPING THE EYE, WHEN THERE WAS A LOUD BOOM. CEILING MICROSCOPE LIGHT BULB BLEW UP, GLASS SHATTERED TO PIECES EVERYWHERE ON THE FLOOR, OTHER EQUIPMENT IN THE ROOM AND BACK TABLE. NEW SET UP OPENED. CHARGE NURSE NOTIFIED. BIOMED NOTIFIED. ZEISS COMPANY NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385314 OPMI LUMERA 700 MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC EPT CARL ZEISS, INC. OPMILUMERA700 *

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR