BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYC-1000

    MDR report key: 5411557 · Received February 4, 2016

    Report

    Report Number
    3002807715-2016-00007
    Event Type
    Malfunction
    Date Received
    February 4, 2016
    Date of Event
    January 7, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NIDEK FIELD SERVICE ENGINEER (FSE) WENT TO THE FIELD FOR DEVICE EVALUATION ON (B)(4) 2016. THE DEVICE WAS TESTED AND EVALUATED BY THE FSE. CUSTOMER COMPLAINT FOR GREEN FLASHBACK COULD NOT BE DUPLICATED. FSE ALSO CHECKED THE PROTECTIVE FILTER AND COULD NOT FIND ANY FAILURE. FSE CHECKED THE ILLUMINATION FOR THE SLIT LAMP AND NO FAILURE WAS FOUND. AFTER THE SERVICE WAS PERFORMED CUSTOMER CALLED BACK AGAIN TO INFORM THAT THEY WERE GETTING ERROR 2 AND ALSO THE SLIT LAMP ILLUMINATION WAS UNCONTROLLABLE. FSE REPLACED THE DEVICE WITH NEW GYC-1000 (SN: (B)(4)). THE CUSTOMER UNIT GYC-1000 SN: (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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED BACK TO NIDEK FOR IN-HOUSE REPAIR. NIDEK IN-HOUSE SERVICE ENGINEER (SE) EVALUATED THE DEVICE ON 02/17/2016. SE TESTED AND EVALUATED THE DEVICE. LASER OUTPUT WAS VERIFIED. NO FAILURE WAS FOUND. NIDEK (B)(4) HAD PERFORMED ADDITIONAL INVESTIGATIONS ON 5/23/2016. 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 (IEC60825-1), THEREFORE, IT IS CONCLUDED THAT THERE IS NO ADVERSE EFFECTS ON DOCTOR'S EYES.

    Description of Event or Problem · 1

    NIDEK INC. RECEIVED A COMPLAINT FROM A CUSTOMER ON (B)(6) 2016. DURING SURGERY WITH GYC-1000, SERIAL NUMBER (SN): (B)(4), DOCTOR WAS GETTING A GREEN FLASHBACK WHENEVER THE LASER WAS FIRED. DOCTOR ALSO REPORTED THAT HE WAS WEARING PROTECTIVE GOGGLES AS A SAFETY. DOCTOR ALSO COMPLAINED THAT THE ILLUMINATION RHEOSTAT COULD NOT BE ADJUSTED AND THE ILLUMINATION WAS AT THE HIGHEST SETTINGS. NO INJURY WAS REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69635 GYC-1000 GREEN LASER PHOTOCOAGULATOR SYSTEM HQF NIDEK CO., LTD. GYC-1000

    Patients

    Seq Age Sex Outcome Treatment
    1