BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCULIGHT GL LASER

    MDR report key: 3042440 · Received January 11, 2013

    Report

    Report Number
    2939653-2013-00001
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 6, 2012
    Report Date
    January 11, 2013
    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 ERROR LOG SHOWED ERROR 5 (LOW POWER). THE AIMING BEAM POWER REGISTERED .618 WATTS, WITHIN SPEC. THE MOST LIKELY CAUSE OF THE FAILURE BASED ON THE ERROR CODE INDICATED IN THE SERVICE MENU WAS LOW POWER FROM THE LASER HEAD. BASED ON THE INVESTIGATION OF THE ERROR CODE THE LASER HEAD WAS REMOVED AND SENT TO THE LASER HEAD SERVICE DEPARTMENT FOR INVESTIGATION AND REPAIR. THE RESULTS OF THE HEAD ROOM INVESTIGATION WERE AS FOLLOWS: LASER DIODE MEETS POWER SPECS, VANADATE CRYSTAL MOUNT IS REMOUNTED AND IS ACCEPTABLE TO SPEC, KTP CRYSTAL HAS BURNED COATING, OUTPUT COUPLER IS REMOUNTED AND IS ACCEPTABLE TO SPEC. AS A RESULT OF THE INITIAL INVESTIGATION IT WAS RECOMMENDED THAT THE KTP CRYSTAL BE REPLACED AND THE LASER HEAD REALIGNED, RE-ADJUSTED AND ALL OPTICS CLEANED. IRIDEX HAS REVIEWED AND UPDATED ITS SERVICE PROCESS, PROCEDURES, AND FORMS TO ENSURE APPROPRIATE TROUBLESHOOTING OF RETURNED PRODUCT. TRAINING HAS BEEN CONDUCTED FOR SERVICE STAFF. F/U DOCUMENTATION FROM THE USER FACILITY INDICATES THE TREATING PHYSICIAN WAS PERFORMING A VITRECTOMY FOR VITREOUS HEMORRHAGE OS WHEN THE ACTUAL LOW POWER WARNING APPEARED DURING TREATMENT. THE USER FACILITY REPORTS THAT A 23G LASER ENDO PROBE WAS IN USE DURING THE FAILURE, BUT THE PROBE WAS NOT RETAINED AS IT WAS DETERMINED TO BE A CONSOLE ISSUE. THUS, THE USER FACILITY DID NOT RETURN THE PROBE. ACCORDING TO THE USER FACILITY THE PT IS RECOVERING.

    Description of Event or Problem · 1

    USER FACILITY REPORTING THE FOLLOWING IN MEDWATCH REPORT (B)(6): "LASER OCULIGHT GL HAD ENERGY 'ACTUAL LOW POWER' WARNING FAILURE DURING SURGERY. THIS IS A LOANER DEVICE. DOSE OR AMOUNT: 300MW POWER; FREQUENCY: 100 INTERVAL 300D; ROUTE: INTRAOCULAR; DATE OF USE: (B)(6) 2012; DIAGNOSIS OR REASON FOR USE: VITREOUS HEMORRHAGE. A 23G LASER ENDO PROBE WAS ALSO USED IN CONJUNCTION WITH THIS DEVICE WHEN ERROR MESSAGE AND AUTOMATIC SHUT OFF OCCURRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19554 OCULIGHT GL LASER LASER THERAPY UNIT GEX IRIDEX CORP. 31214

    Patients

    Seq Age Sex Outcome Treatment
    1