BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE E85

    MDR report key: 502822 · Received December 18, 2003

    Report

    Report Number
    1720381-2003-00002
    Event Type
    Malfunction
    Date Received
    December 18, 2003
    Date of Event
    November 11, 2003
    Report Date
    December 12, 2003
    Manufacturer
    LUMENIS, INC.
    Product Code
    HQB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICAN WAS PERFORMING PANRETINAL PHOTOCOAGULATION FOR THROMBOSIS OF THE MAIN CENTRAL RETINAL VEIN USING THE ELITE AT PARAMETERS OF 200MW, 200 MICRON SPOT AND 0.1 SECOND EXPOSURE. A SUDDEN HEMORRHAGE OCCURRED AND COMPLETELY OBSCURED TREATMENT VISIBILITY. TREATMENT WAS TERMINATED. NO FURTHER MEDICAL INTERVENTION WAS PERFORMED. PATIENT VISION PRIOR TO TREATMENT WAS 20/200 AND FOLLOWING THE SUBSEQUENT HEMORRHAGE, THE PATIENT HAD NO VISION IN THE TREATED EYE. PHYSICIAN EXPECTS VISION TO RETURN TO 20/200 ONCE BLOOD IN THE FIELD IS ABSORBED. FOLLOW-UP IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELITE E85 OPHTHALMIC LASERS HQB LUMENIS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other