BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCULIGHT GLX LASER

    MDR report key: 2110930 · Received March 25, 2011

    Report

    Report Number
    2939653-2010-00005
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    August 18, 2010
    Report Date
    March 25, 2011
    Manufacturer
    IRIDEX CORP.
    Product Code
    HQF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY RISK (B)(4), WAS CONTACTED BY PHONE ON (B)(6) 2011 TO F/U ON PT STATUS. MS (B)(4)STATED THAT THE PT HAD A SCHEDULED APPOINTMENT ON (B)(6) 2010 IN THE AMBULATORY UNIT. IRIDEX SCHEDULED A LOANER DEVICE TO BE DELIVERED ON (B)(6) 2010, AND THE USER FACILITY AGREED TO RESCHEDULE THE PT FOR THE INTENDED PROCEDURE. MS (B)(4) STATED THAT SHE WAS NOT AWARE OF ANY COMPLICATIONS WITH THE PT AS A RESULT OF THE PRODUCT MALFUNCTION ON (B)(6) 2010. THE DEVICE WAS RETURNED TO IRIDEX AND EVALUATED BY THE SVC DEPT. THE INVESTIGATION IDENTIFIED THAT THE HEAD BOARD AND HEATER BOARD WERE BURNED. BOTH BOARDS WERE REPLACED. THE DEVICE WAS THEN TESTED AND IT MET PERFORMANCE SPECIFICATIONS. IRIDEX INITIATED AN APPROPRIATE CORRECTIVE ACTION TO ADDRESS THE REPORTED PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    USER FACILITY REPORTS IRIDEX LASER HAS A SELF-TEST MODE. EQUIPMENT WAS TESTED AND WARNING READ "HEATING DELTA 13.4C". EQUIPMENT WAS NOT USED ON THE PT. EQUIPMENT SENT OUT FOR REPAIR. USER FACILITY REPORTS THAT THE EVENT DID NOT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE. USER FACILITY REPORTS THAT THE ORIGINAL INTENDED PROCEDURE WAS A VITRECTOMY WITH LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCULIGHT GLX LASER LASER THERAPY UNIT HQF IRIDEX CORP. OCULIGHT GLX LASER

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR