BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPHTHALAS 532 EYELITE

    MDR report key: 498746 · Received November 20, 2003

    Report

    Report Number
    2028159-2003-00220
    Event Type
    Malfunction
    Date Received
    November 20, 2003
    Date of Event
    October 21, 2003
    Report Date
    October 21, 2003
    Manufacturer
    ALCON-IRVINE TECHNOLOGY CENTER
    Product Code
    HQB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED LASER SHUT OFF DURING USE. SERVICE REQUEST MESSAGE APPEARED AND SYSTEM COULD NOT BE RESTARTED. CHANGED LASERS TO COMPLETE CASE. PT WAS UNDER ANESTHESIA DURING A FORTY-FIVE MINUTE DELAY. NO INJURY, BUT SURGEON FELT THIS COULD CAUSE A MAJOR PROBLEM IF IT RECURS. PT CONDITION REPORTED AS GUARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPHTHALAS 532 EYELITE LASER PHOTOCOAGULATOR HQB ALCON-IRVINE TECHNOLOGY CENTER 532 EYELITE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO