BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERLUX 301

    MDR report key: 1278663 · Received December 16, 2008

    Report

    Report Number
    1278663
    Event Type
    Malfunction
    Date Received
    December 16, 2008
    Date of Event
    November 8, 2008
    Report Date
    December 16, 2008
    Manufacturer
    CARL ZEISS, INC.
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MS, US

    Narratives

    Description of Event or Problem · 1

    MICROSCOPE LIGHT SOURCE FAILED TWICE DURING THE PROCEDURE. THE LIGHT WAS TURNED OFF FOR APPROXIMATELY FIVE MINUTES AND ALLOWED TO COOL. THE LIGHT DID COME BACK ON, BUT THE CASE WAS DELAYED DUE TO LIGHT SOURCE FAILURE. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERLUX 301 LIGHT SOURCE, SURGICAL MICROSCOPE EPT CARL ZEISS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR NO OTHER THERAPIES| NO OTHER THERAPIES