BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MC-500

    MDR report key: 8382740 · Received March 1, 2019

    Report

    Report Number
    0002936921-2019-00004
    Event Type
    Malfunction
    Date Received
    March 1, 2019
    Date of Event
    February 6, 2019
    Report Date
    March 1, 2019
    Manufacturer
    NIDEK CO. LTD.
    Product Code
    HQF
    PMA / PMN Number
    K111493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON FEBRUARY 13, 2019, A NIDEK INC. FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE IN QUESTION AT THE USER'S FACILITY. THE CUSTOMER REPORTED ISSUE "POWER ABSORPTION NOT CONSISTENT" COULD NOT BE VERIFIED OR DUPLICATED. NO ERRORS WERE PRESENT IN THE ERROR LOG. FSE TESTED THE POWER OUTPUT FROM THE DEVICE AND MEASURED THE POWER FOR ALL THREE LASERS AT 120MW. GREEN= 120MW, RED= 120MW, YELLOW= 116MW. FSE TESTED THE SYSTEM AT 240 MICRON SPOT SIZE, 300MW GREEN, 0.05SECONDS EXPOSURE TIME, 4*4 SCAN GRID. ALL GRID BURNS WERE UNIFORM. POWER WAS MEASURED AT 275MW WITH NO SPIKES DETECTED. FSE PERFORMED PREVENTIVE MAINTENANCE OF THE DEVICE AS A PRECAUTIONARY MEASURE. THE INTERNAL COMPONENTS WERE INSPECTED AND FIBERS AND CABLES WERE ORGANIZED. CLEANED THE INTERNAL OPTICAL LASER PATH FOR GREEN, YELLOW AND RED BEAMS, SLIT-LAMP OCULARS, VIXI DELIVERY OPTICS, AND B.I.O. OPTICS. CALIBRATED POWER OUTPUT AND DISPLAY PARAMETERS FOR BOTH DELIVERIES. CHECKED MICRO-SWITCHES OF FOOT-SWITCH FOR PROPER ADJUSTMENT. VERIFIED: 50 -500 MICRON FOCUS AND ALIGNMENT WITH SLIT ILLUMINATION IS PROPER. VIXI SCAN DELIVERY PATTERNS ARE PROPER. BIO ALIGNMENT AND OPERATION. SYSTEM OPERATION AT ALL SETTINGS. SYSTEM IS OPERATIONAL. NO PROBLEM WAS FOUND DURING TESTING AND INSPECTION. CUSTOMER REPORTED ISSUE COULD NOT BE VERIFIED AND IS INCONCLUSIVE.

    Description of Event or Problem · 1

    NIDEK INC. RECEIVED A COMPLAINT FROM A CUSTOMER REPORTING THAT DURING THE USE OF THEIR MULTICOLOR LASER PHOTOCOAGULATOR MC-500 SN: (B)(4), ONE OF THE SURGEONS SAW DIFFERENT LASER POWER ABSORPTION THROUGHOUT THE SCAN PATTERN, SOME SPOTS WERE TOO STRONG WHILE PERFORMING A PRP PROCEDURE (PAN RETINAL PHOTOCOAGULATION) ON (B)(6) 2019. CUSTOMER REQUESTED SERVICE. NO INJURY TO PATIENTS WAS REPORTED THAT TIME. ON (B)(6) 2019 THE CUSTOMER CONFIRMED THAT THE PATIENT INVOLVED IN THE PRP PROCEDURE IS DOING FINE. THE SURGEON WAS ABLE TO FINISH LASER TREATMENT BY CHANGING TO A DIFFERENT SETTING ON THE LASER. ADDITIONAL PATIENT INFORMATION WAS NOT PROVIDED. NIDEK INC. CONSIDERS THIS ISSUE ON MC-500 AS A REPORTABLE EVENT AS AN UNDESIRABLE CONDITION OCCURRED WHILE USING THE DEVICE THAT HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. TECHNICAL BACKGROUND: THE LASER PHOTOCOAGULATION WITH MC-500 IS ACHIEVED BY HEAT GENERATION BY ABSORPTION OF LASER ENERGY THAT REACHES THROUGH OCULAR MEDIA INTO THE PIGMENT OF RETINA OR CHOROID. NORMALLY, PROTEIN COAGULATES AND BECOMES WHITE WHEN ITS TEMPERATURE RISES TO APPROXIMATELY 70°C OR MORE. THE DEGREE OF COAGULATION CAN BE JUDGED BY OBSERVING THE WHITE SPOT. THE GENERATION OF WHITE SPOT DEPENDS ON THE TREATMENT BEAM EMISSION RANGE. THE TRANSMISSION OF THE LASER ENERGY BY THE OCULAR MEDIA AND DEPTH OF THE AREA OF HEAT GENERATION ALSO DIFFER ACCORDING TO THE WAVELENGTH. THE GREATER THE LASER POWER BECOMES AND THE LONGER THE EXPOSURE TIME ELAPSES, MORE HEAT IS GENERATED. AS A RESULT, THE COAGULATION EFFECT ON THE SURROUNDING TISSUE IS ENHANCED. TO REDUCE THE RISK OF UNINTENDED COAGULATION EFFECT, IT IS RECOMMENDED TO START THE TREATMENT USING THE SINGLE SPOT WITH THE LOWEST POWER OUTPUT. THEN GRADUALLY INCREASE THE POWER OUTPUT, THEN EXECUTE PHOTOCOAGULATION IN SCAN MODE WITH THE POWER OUTPUT WITH WHICH THE INTENDED EFFECTS CAN BE ACHIEVED. THE MC-500 HAS SEVERAL PREPROGRAMMED SCAN PATTERNS TO ALLOW TREATMENT OF VARYING RETINAL PATHOLOGIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174304 MC-500 MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM HQF NIDEK CO. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR