BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTA DUET

    MDR report key: 5063755 · Received September 9, 2015

    Report

    Report Number
    5063755
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Date of Event
    July 13, 2015
    Report Date
    August 5, 2015
    Manufacturer
    LUMENIS, INC.
    Product Code
    HQF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN PREPARING TO BEGIN LASER TREATMENTS ON SIX PATIENTS, THE LASER PRODUCED AN ERROR MESSAGE. THE PATIENTS HAD ALREADY RECEIVED EYE DROPS IN PREPARATION FOR THE PROCEDURE. MD WAS PRESENT. CONTACTED REPRESENTATIVES OF LUMENIS (OPHTHALMOLOGY/LASER MANUFACTURER) IT WAS DETERMINED THAT THE LASER WOULD REQUIRE REPAIR BEFORE TREATMENT OF PATIENTS. ATTEMPTS TO REBOOT THE LASER WERE UNSUCCESSFUL. LUMENIS SCHEDULED TO COME IN THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596986 SELECTA DUET LASER, OPHTHALMIC HQF LUMENIS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR