BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYC-1000

    MDR report key: 8339810 · Received February 14, 2019

    Report

    Report Number
    0002936921-2019-00002
    Event Type
    Malfunction
    Date Received
    February 14, 2019
    Date of Event
    January 16, 2019
    Report Date
    February 14, 2019
    Manufacturer
    NIDEK CO. LTD.
    Product Code
    HQF
    PMA / PMN Number
    K032085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NIDEK FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER FACILITY FOR DEVICE EVALUATION ON (B)(6) 2019. THE DEVICE WAS TESTED AND EVALUATED BY THE FSE. CUSTOMER COMPLAINT FOR GREEN LASER REFLECTION FROM THE DEVICE GYC-1000 SERIAL NUMBER: (B)(4) COULD NOT BE DUPLICATED. THE GYC-1000 WAS USED IN COMBINATION YAG LASER YC-1800 SERIAL NUMBER: (B)(4) WITH COMBO ADAPTOR GYC2SZ-3A SERIAL NUMBER: (B)(4). FSE POWERED ON THE SYSTEM AND FOUND IN WORKING ORDER. SHOT COUNTER FOR GYC-1000 WAS RECORDED AS 38*1000 AND FOR YC-1800 AS 12*1000. FSE NOTICED THE ILLUMINATION TOWER WAS ANGLED IN FRONT OF THE COMBO DELIVERY'S TURNING MIRROR. THE MIRRORS REFLECT THE ILLUMINATION LIGHT FOR OBSERVATION TO THE PATIENT'S EYE. FSE CONFIRMED THAT NO ERROR 2 WAS DISPLAYED FOR A PROTECTIVE FILTER PROBLEM. FSE OBSERVED PROPER OPERATION OF THE PROTECTIVE FILTER WHEN OPERATING THE GYC1000 AT THE DISPLAYED SETTINGS: 50 MICRON SPOT SIZE, POWER = 850MW, TIME = 0.02 SECONDS. FSE REMOVED THE PROTECTIVE FILTER ASSEMBLY, AFTER INSPECTION, AND FOUND IT TO BE IN WORKING ORDER. THE MECHANICAL PARTS AND ELECTRICAL TIMING OF THE FILTER PLATE ARE PROPER. THE PROTECTIVE FILTER ASSEMBLY WAS REINSTALLED AND TESTING WAS PERFORMED AT ALL SETTINGS WITHOUT FAILURE TO FILTER THE GREEN LASER BEAM PROPERLY. FSE CLEANED THE COMBO DELIVERY AND YC-1800 OPTICS. AND ORGANIZED THE FIBER OPTIC AND POWER CABLES UNDER THE K2 TABLE TOP. FSE VERIFIED : GYC POWER OUTPUT IS IN SPEC 50 -1500MW AND THE PROTECTIVE FILTER IS WORKING PROPERLY. YC1800 ENERGY OUTPUT IS IN SPEC 0.2 - 10.8MJ LASER / AIMING BEAMS ARE IN FOCUS AND PROPERLY ALIGNED. THE SYSTEM WAS TESTED AND INSPECTED. THE SYSTEM IS OPERATIONAL. THEREBY, NIDEK INC. DETERMINED THAT THE CUSTOMER STATED COMPLAINT WAS INCONCLUSIVE AS THE ISSUE COULD NOT BE DUPLICATED AND NO PROBLEM WAS FOUND DURING DEVICE EVALUATION. FSE INTERPRETED THAT THE DOCTOR SAW SOME SCATTERED REFLECTION IN THE ROOM AND NOT A FLASHBACK OF GREEN LIGHT. THERE IS POSSIBILITY THAT SUCH REFLECTION COULD OCCUR EITHER FROM THE ILLUMINATION TOWER OR FROM THE CONTACT LENS IF USED. THE ILLUMINATION TOWER BEING IN FRONT OF THE LASER DELIVERY'S TURNING MIRROR MAY HAVE CONTRIBUTED TO ADDED SCATTERING OF THE GREEN LASER BEAM DURING PATIENT TREATMENT IN THIS CASE. FSE ADVISED THE CUSTOMER TO BE CAUTIOUS OF ITS POSITION. THE OPERATORS MANUAL FOR THE COMBO DELIVERY MODES CAUTIONS THE FOLLOWING: WHEN USING THE ILLUMINATION TOWER UNIT FOR LASER, MOVE THE ILLUMINATION ARM 20° OR MORE TO THE LEFT OR RIGHT FORM THE CENTER SO THAT IT DOES NOT BLOCK THE YAG LASER BEAM. ON (B)(6) 2019, THE CUSTOMER CONFIRMED THAT THE LASER WAS FUNCTIONING AS EXPECTED. THE DOCTOR HAS COMPLETED TWO SURGERIES SINCE THE SERVICE WAS PERFORMED AND HAS ANOTHER SCHEDULED ON 02.12.2019.

    Description of Event or Problem · 1

    NIDEK INC. RECEIVED A COMPLAINT ON (B)(6) 2019 THAT A DOCTOR GOT A REFLECTION OF THE LASER ONTO HER. THE ISSUE OCCURRED WHILE USING THE LASER, GYC-1000 (S/N (B)(4)) IN COMBINATION WITH SLIT LAMP, YC-1800 (S/N (B)(4)). NO INJURY WAS REPORTED THAT TIME. NIDEK INC. CONSIDERS THIS IS AS AN UNDESIRABLE CONDITION AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. NIDEK INC. REPRESENTATIVES CONTACTED THE CUSTOMER REGARDING ADDITIONAL PATIENT INFORMATION AND THE REPORTED PROBLEM. FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION BECOMES AVAILABLE AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133484 GYC-1000 GREEN LASER PHOTOCOAGULATOR SYSTEM HQF NIDEK CO. LTD. GYC-1000

    Patients

    Seq Age Sex Outcome Treatment
    1