BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCULIGHT GL LASER

    MDR report key: 2963609 · Received November 30, 2012

    Report

    Report Number
    2939653-2012-00009
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    September 27, 2011
    Report Date
    November 30, 2012
    Manufacturer
    IRIDEX CORP.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A FAILURE ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE - SERIAL NUMBER (B)(4). THE INVESTIGATION CONFIRMED LOW POWER EMISSION. THE TECH REALIGNED THE LASER CAVITY, REPLACED THE HEATSINK AND THERMISTOR, READJUSTED THE TEMPERATURE, CLEANED THE OPTICS, AND RECALIBRATED THE UNIT. FOLLOW-UP DOCUMENTATION FROM THE USER FACILITY INDICATES THE TREATING PHYSICIAN WAS PERFORMING A VITRECTOMY WITH REPAIR OF RETINAL DETACHMENT. THE TREATING PHYSICIAN "TRIED MULTIPLE DIFFERENT SETTINGS, POWER CHANGED, DURATION AND INTERVAL WHICH DID NOT WORK TO PROVIDE DESIRED EFFECT; THEREFORE, CRYOPEXY WAS PERFORMED." IT WAS REPORTED THAT THE ENDOPROBE (IRIDEX 23G ADJUSTABLE AND INTUITIVE ENDOPROBE, PART NUMBER 147573T) IDENTIFIED IN THE MEDWATCH REPORT (#(B)(6)) WAS USED. THE USER FACILITY REPORTS THAT "THE LASER INDIRECT OPHTHALMOSCOPE (LIO) WAS ALSO USED, BUT THE DOCTOR HAD THE POWER FAILURE WITH BOTH DEVICES AND IT WAS RULED TO BE THE CONSOLE FAILURE." THUS, THE USER FACILITY DID NOT RETURN THE PROBE, NOR THE LIO, TO IRIDEX FOR INVESTIGATION. ACCORDING TO THE USER FACILITY, "THE PT IS DOING WELL, BUT DID REQUIRE ADDITIONAL LASERING IN THE OFFICE." ON (B)(6) 2012, IRIDEX REPS SPOKE WITH (B)(6), RN, WHO FILED THE REPORT (#(B)(6)), TO REVIEW THE DEVICE HISTORY RECORD AND DISCUSS USAGE OT THE UNIT. THE IRIDEX REP LOCAL TO THE USER FACILITY IS SCHEDULED TO MEET WITH (B)(6) TO FURTHER REVIEW THE PRODUCT'S USAGE.

    Description of Event or Problem · 1

    ON (B)(6) 2012, TRIDEX CORPORATION RECEIVED A COPY OF MEDWATCH REPORT #(B)(6) FILED BY A USER FACILITY ON (B)(6) 2012. IN THAT REPORT, THE USER FACILITY REP STATES THE "EQUIPMENT FAILED TO EMIT POWER AS DESIRED. REASON FOR USE: RETINAL DETACHMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCULIGHT GL LASER LASER THERAPY UNIT GEX IRIDEX CORP. 31214

    Patients

    Seq Age Sex Outcome Treatment
    1