BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVUS 2000

    MDR report key: 606306 · Received May 5, 2005

    Report

    Report Number
    606306
    Event Type
    Malfunction
    Date Received
    May 5, 2005
    Date of Event
    March 18, 2005
    Report Date
    May 5, 2005
    Manufacturer
    LUMENIS INC
    Product Code
    HQF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NOVUS 2000 LASER WAS SET TO POWER 3000, DURATION .2, REPEAT 3.3. THE LASER WAS USED BY MD, WHEN MACHINE WAS PUT ON STANDBY, THE REPEAT SETTING HAD GONE TO 2.8 WITHOUT TOUCHING THE SETTING CONTROL. THE LASER SERVICED THE DAY PRIOR TO THE EVENT. FOLLOW UP REVEALS: THE PROCEDURE THE LASER WAS USED FOR WAS A VITRECTOMY, SCLERAL BUCKLE AND THE SETTING USED FOR THIS PROCEDURE WAS WITHIN THE NORMAL LIMITS. THE MANUFACTURER OF THE PRODUCT WAS CONFIRMED TO BE COHERENT MEDICAL AND LUMENIS IS THE COMPANY THAT NOW SUPPORTS THAT PRODUCT. A SEPARATE COMPANY IS THE COMPANY RESPONSIBLE FOR THE REPAIR. ITS LAST SERVICE WAS APPROX 4 MONTHS PRIOR TO THE EVENT. AFTER THE EVENT IT WAS DETERMINED BY THE SERVICE THAT A FRACTURED FIBER OPTIC WIRE HAD CAUSED THE PROBLEM AND THE WIRE WAS REPLACED BEFORE THE LASER WAS USED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVUS 2000 OPHTHALMOPATHY LASER HQF LUMENIS INC A5857 *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR