BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYC-1000

    MDR report key: 5488122 · Received March 8, 2016

    Report

    Report Number
    3002807715-2016-00013
    Event Type
    Malfunction
    Date Received
    March 8, 2016
    Date of Event
    February 10, 2016
    Report Date
    May 23, 2016
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    HQF
    PMA / PMN Number
    K032085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO NIDEK FOR ADDITIONAL EVALUATION. NIDEK IN HOUSE SERVICE ENGINEER (SE) EVALUATED THE DEVICE ON 04/21/2016. NO DEVICE FAILURE WAS OBSERVED BY IN-HOUSE SERVICE ENGINEER. AS PER FIELD SERVICE ENGINEER(FSE) WHO CHECKED THE DEVICE ON SITE, STATED THAT ONE POSSIBLE REASON FOR THIS COMPLAINT IS THAT THE OPERATOR MAY HAVE LEFT THE BIO TERMINATOR PLUG IN THE GYC1000 AFTER CHANGING THE FIBER OPTIC THAT WAS PLUGGED IN THE CONSOLE FOR THE BIO TO THE FIBER FOR THE COMBO DELIVERY. THE LASER WOULD OPERATE IN BIO MODE, SO THE PROTECTIVE FILTER WOULD NOT CLOSE AND NO ERROR INDICATED EVEN THOUGH THE LASER BEAM IS BEING DELIVERED THROUGH THE COMBO DELIVERY AND EXPOSING THE OPERATOR LOOKING THROUGH THE OCULARS. HOWEVER, THE CAUSE COULD NOT BE CONFIRMED. THE ISSUE HAD BEEN DISCUSSED WITH THE ON DUTY DOCTOR THAT TIME. FSE ALSO CONFIRMED THAT THE LASER WAS SET UP PROPERLY AT THE FACILITY. ADDITIONAL INVESTIGATIONS WERE PERFORMED BY NIDEK (B)(4) ON 5/23/2016 TO FIND OUT THE ROOT CAUSE. DHR WAS INVESTIGATED AT NIDEK (B)(4) (NCO), AND CONFIRMED THAT THE ALL REQUIREMENT FOR NIDEK QUALITY STANDARD HAS PASSED AT NIDEK INSPECTION IN (B)(4). NIDEK (B)(4) IMPLEMENTED INVESTIGATION FOR SIMILAR SYMPTOMS FROM THE PAST DUE TO THE PRODUCT IS NOT SENT IN NIDEK (B)(4). AS PER THE INVESTIGATION, IN GENERAL, PEOPLE FEEL "BRIGHTER" IN CASE OF; THE LASER WAVELENGTH IS CLOSER TO A PEAK OF LUMINOUS SENSITIVITY (ABOUT 550NM). THE SELECTED LASER POWER IS 1W WHICH IS CONSIDERED AS HIGH POWER. THEREFORE, FROM THOSE REASONS, WE CONSIDER THAT THE DOCTOR FELT BRIGHTER. HOWEVER, THE REFLECTION LIGHT IS SUFFICIENTLY BELOW MPE VALUE BASED ON THE STANDARD ((B)(4)), THEREFORE, IT IS CONCLUDED THAT THERE IS NO ADVERSE EFFECTS ON DOCTOR'S EYES.

    Additional Manufacturer Narrative · 1

    NIDEK FIELD SERVICE ENGINEER (FSE) WENT TO THE FIELD FOR DEVICE EVALUATION ON 02/23/2016. THE DEVICE WAS EVALUATED BY THE FSE. CUSTOMER COMPLAINT FOR GREEN FLASHBACK COULD NOT BE DUPLICATED. FSE ASKED TO THE DOCTOR WHO SAW THE FLASHBACK, THAT IF THE LASER WAS SET UP PROPERLY AND THAT DOCTOR REPLIED YES. THE CUSTOMER UNIT GYC-1000, (B)(4) WILL BE RETURNED BACK TO NIDEK FOR FURTHER EVALUATION. IF ADDITIONAL SIGNIFICANT INFORMATION IS AVAILABLE AT A LATER DATE AFTER THE EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME THERE WAS NO INJURY/ ADVERSE EVENT OCCURRED SO NO PATIENT INFORMATION IS AVAILABLE. NIDEK CONSIDERS THIS FAILURE MODE A REPORTABLE EVENT AS THE DEVICE HAS MALFUNCTIONED AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    NIDEK INC. RECEIVED A COMPLAINT FROM CUSTOMER ON (B)(6) 2016. CUSTOMER REPORTED THAT DURING THE USE OF GYC-1000 SN: (B)(4), DOCTOR WAS GETTING GREEN FLASHBACK THROUGH SLIT LAMP. THERE WAS NO FLASHBACK WHEN DOCTOR USED THE INDIRECT OPHTHALMOSCOPE. NO INJURY WAS REPORTED THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142505 GYC-1000 GREEN LASER PHOTOCOAGULATOR SYSTEM, HQF NIDEK CO., LTD. GYC-1000

    Patients

    Seq Age Sex Outcome Treatment
    1