BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUXOR

    MDR report key: 3080891 · Received April 24, 2013

    Report

    Report Number
    2028159-2013-00722
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    GES
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING A PROCEDURE, THE VIDEO WOULD NOT DISPLAY ON THE MONITOR. AN ALTERNATE MICROSCOPE WAS USED. THE CASE WAS COMPLETED WITHOUT HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177736 LUXOR MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, O GES ALCON - IRVINE TECHNOLOGY CENTER LUXOR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INFINITI VISION SYSTEM