BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYC-1000

    MDR report key: 6311922 · Received February 8, 2017

    Report

    Report Number
    0002936921-2017-00001
    Event Type
    Malfunction
    Date Received
    February 8, 2017
    Date of Event
    January 10, 2017
    Report Date
    December 11, 2017
    Manufacturer
    NIDEK INCORPORATED
    Product Code
    HQF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE ON THE DEVICE WAS PERFORMED AT CUSTOMER'S SITE AND A NIDEK INC. FIELD SERVICE ENGINEER (FSE) WAS ABLE TO VERIFY ABNORMAL FLASHING THROUGH THE OCULARS WHEN THE LASER WAS FIRED. · FSE CHECKED SHOT COUNTER YC1800 = 70 X 1000, GYC-1000 = 1 X 1000, ERROR 2 STORED IN MEMORY. POWERED ON BOTH LASERS, YC-1800 : THE 10 SECOND COUNTDOWN WAS NORMAL. GYC-1000 - THE 20 SECOND COUNT DOWN WAS NORMAL BUT THE GYC-1000'S DISPLAY STAYED ON EVEN WHEN THE COMBO'S SWITCH WAS IN THE YC POSITION. IN GYC-1000 MODE, THE PROPER SPOT SIZE WAS DISPLAYED. TEST FIRED THE LASER, THE PROTECTIVE FILTER DID NOT MOVE BUT THE GREEN LASER WAS STILL EMITTED, NO ERROR 2 DISPLAYED. · FSE INSPECTED THE COMBO DELIVERY AND MOUNTED IT PROPERLY TO THE YC-1800. INSPECTED THE GYC-1000 CONNECTIONS AND FOUND THE COMBO DELIVERY CONTROL CABLE LOOSE IN THE CONNECTION PORT OF THE CONSOLE. WHEN THE CABLE WAS MOVED, THE PROTECTIVE FILTER PULSED AND ERROR 2 WAS DISPLAYED. · AFTER TURNING OFF THE GYC-1000 AND RESEATING THE CONTROL CABLE PROPERLY, THE LASER FUNCTIONED PROPERLY. ·AS A PRECAUTIONARY MEASURE, NIDEK INC. SENT A LOANER TO THE CUSTOMER AND THE USER'S GYC-1000 WAS SENT BACK TO NIDEK INC. FOR FURTHER EVALUATION. A FOLLOW-UP REPORT OF THE OUTCOME INVESTIGATION WILL BE SUBMITTED. · THE PHYSICIAN REPORTED TEMPORARY BLINDNESS IN HIS PERIPHERAL VISION CALLED ON (B)(6) 2017 AT 1:30PM AND STATED THAT HE WAS STILL EXPERIENCING INTERMITTENT BLURRING 3-4 WEEKS AFTER THE INCIDENT. HE IS PLANNING TO SCHEDULE TO HAVE HIS EYES CHECKED FOR MEDICAL EVALUATION AND WILL INFORM NIDEK INC THE OUTCOME RESULT OF THE EVALUATION AND IF ANY MEDICAL OR SURGICAL TREATMENT NEEDED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT IN QUESTION, GYC-1000 WAS RECEIVED AT NIDEK INC. AND EVALUATED IN-HOUSE. THE DEVICE WAS TESTED AND INSPECTED BY A SERVICE ENGINEER AND FOUND NO PROBLEM WITH THE DEVICE. THE CONTROL CABLE AND THE CONSOLE'S CONNECTOR PORT HAD NO ISSUE. THE PROTECTIVE FILTER WAS WORKING PROPERLY AFTER FIRING OVER 1,300 SHOTS. ACCORDING TO SE, THE DOCTOR BILATERAL SCOTOMAS (VISUAL DISTURBANCE) MAY HAVE BEEN CAUSED BY HIGH VALUE ENERGY POWER THAT TRIGGERED THE BRIGHT FLASH THAT LIT UP THE ROOM. BASED ON AN EMAIL CONFIRMATION FROM THE DOCTOR, THE SETTINGS USED AT THAT TIME OF OCCURRENCE WERE; ENERGY POWER AT 800-900, 0.1 SECOND, 50 MICRON SPOT SIZE, SINGLE BURST, WHICH IS CONSIDERED THE HIGHEST MAXIMUM VALUE SETTING ON THE LASER. THE DOCTOR WITH TEMPORARY BLIND SPOT WAS EXAMINED BY A RETINAL SURGEON ON (B)(6) 2017, AND WITH A COMPLETE EYE EXAMINATION INCLUDING DILATION AND OCT AND DID NOT FIND ANY DAMAGE. NIDEK INC. CONCLUDES THAT THE LOOSE CONTROL CABLE THAT WAS ORIGINALLY FOUND TO BE THE CAUSE OF THE ABNORMAL FLASHING WAS NOT THE PROBABLE OR ROOT CAUSE. WHEN THE CABLE IS NOT CONNECTED FLUSHED IN THE PORT, THE LASER AUTOMATICALLY PROMPTS AN ERROR 2 AND LASER FIRING IS DISABLED. NO PROBLEM FOUND DURING IN-HOUSE DEVICE EVALUATION. THEREBY, NIDEK INC DETERMINED THAT THE CUSTOMER'S COMPLAINT ISSUE WAS INCONCLUSIVE.

    Additional Manufacturer Narrative · 1

    NIDEK INC. WAS UNABLE TO DUPLICATE THE PROBLEM OF ABNORMAL FLASHING REPORTED BY THE CUSTOMER. THE ISSUE WAS INVESTIGATED FURTHER UNDER NIDEK INC.'S CAPA # (B)(4). THE SUBSEQUENT INVESTIGATION WAS ALSO UNABLE TO DUPLICATE AND/OR VERIFY THE "ABNORMAL FLASHING" ISSUE. HOWEVER, IT WAS CONSIDERED THAT PROBABLE ROOT CAUSE OF THE ISSUE COULD BE DUE TO CONTACT FAILURE IN THE DELIVERY RECOGNITION SIGNAL AT THE DELIVERY CONNECTOR ON THE MAIN BODY AND POSSIBILITY OF A LOOSE MOUNT OF THE COMBO DELIVERY. AS A RESULT, THE RISK MANAGEMENT RECORD FOR THE COMBO DEVICE YC-1800 HAS BEEN UPDATED. ADDITIONALLY GYC-1000 INSTALLATION CHECKLIST AND PREVENTIVE MAINTENANCE CHECKLISTS IS BEING UPDATED TO INCLUDE CHECKING THE FOLLOWING: EACH CONNECTOR IS CONNECTED TO THE CONSOLE APPROPRIATELY. MAKE SURE THE PROTECTIVE FILTER FUNCTIONS PROPERLY. DELIVERY/ SCAN DELIVERY UNIT MOUNTS PROPERLY.

    Description of Event or Problem · 1

    BASED ON CUSTOMER SERVICE ORDER #(B)(4), NIDEK INC. CUSTOMER SERVICE RECEIVED A TELEPHONE CALL FROM A CUSTOMER ON (B)(6) 2017 TO REPORT THAT ABNORMAL FLASHING DURING PROCEDURE WHILE USING THEIR COMBO YAG LASER YC-1800 SERIAL #(B)(4) AND GYC-1000 SERIAL #(B)(4).

    Description of Event or Problem · 1

    SEE INITIAL MDR 0002936921-2017-00001 FOR DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94434 GYC-1000 GREEN LASER HQF NIDEK INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR