BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYC-1000

    MDR report key: 8404689 · Received March 8, 2019

    Report

    Report Number
    0002936921-2019-00005
    Event Type
    Malfunction
    Date Received
    March 8, 2019
    Date of Event
    February 22, 2019
    Report Date
    March 22, 2019
    Manufacturer
    NIDEK. CO. LTD.
    Product Code
    HQF
    PMA / PMN Number
    K032085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON MARCH 20, 2019, NIDEK INC'S QA SPECIALIST CONTACTED THE CUSTOMER BY PHONE AND IN RESPONSE, IT WAS ACKNOWLEDGED THAT THE FACILITY DOCTOR WHO EXPERIENCED FLASHBACK WAS FINE, NO MEDICAL INTERVENTION WAS REQUIRED. THE DOCTOR ALSO INFORMED THAT THE FLASHBACK WAS A ONE-TIME OCCURRENCE AND CONFIRMED THAT SHE WAS NOT EXPOSED THE BEAM.

    Description of Event or Problem · 0

    PLEASE SEE THE INITIAL MDR SUBMITTED ON 08-MAR-2019.

    Additional Manufacturer Narrative · 1

    NIDEK FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE FOR DEVICE EVALUATION ON 02/22/2019. SYSTEM IS A SL-1600 SLIT LAMP WITH A KEELER ALL PUPIL II BIO S/N (B)(4). SYSTEM HAS A DUAL DELIVERY BOX CONNECTED TO THE SLIT LAMP AND BIO. THE DUAL DELIVERY BOX IS SERIAL NUMBER (B)(4). THE DUAL DELIVERY UNIT IS USED IN CONNECTION WITH THE GREEN LASER PHOTOCOAGULATOR GYC-1000. USING THIS UNIT ENABLES CONNECTION OF TWO TYPES OF DELIVERY UNITS TO A UNIT OF GYC-1000. THE DESIRED CONNECTED DELIVERY UNIT CAN BE SELECTED AND USED WITH EASY SWITCHING. CUSTOMER COMPLAINT FOR PROTECTIVE FILTER NOT CLOSING DURING LASER FIRING ON THE DEVICE GYC-1000 SERIAL NUMBER: (B)(4) COULD NOT BE REPRODUCED OR VERIFIED. FSE TURNED THE SYSTEM ON AND NO ERRORS OCCURRED. ALL CABLES RUNNING TO AND FROM THE SYSTEM ARE CONNECTED TO THEIR PROPER DEVICES. SWITCHING BETWEEN SLIT LAMP AND BIO ON THE DUAL DELIVERY BOX SELECTS THE PROPER FIBER TO THE SLIT LAMP OR BIO. NO ERRORS WERE OBSERVED WHEN SWITCHING BETWEEN SLIT LAMP AND BIO ON THE DUAL DELIVERY BOX. FSE TESTED THE DUAL DELIVERY BOX FOR PROPER OPERATION AND PROPER OUTPUT ENERGY. ENERGY OUT OF THE DUAL DELIVERY IS 300MW=287MW ON THE SLIT LAMP SETTING. ENERGY OUT OF THE DUAL DELIVERY IS 300MW= 302MW ON THE BIO SETTING. ALL THE WIRING AND CONTROL SURFACES OF THE DUAL DELIVERY BOX WERE WORKING PROPERLY. THE PROTECTIVE FILTER WAS FOUND TO BE WORKING PROPERLY ALSO. THE ISSUE WAS DISCUSSED WITH THE DUTY DOCTOR, DOCTOR (B)(6) AT THE CUSTOMER SITE. WHILE OPERATING THE DEVICE, WHEN THE CUSTOMER SWITCHED FROM BIO TO SLIT LAMP ON THE DUAL DELIVERY BOX, AN UNSPECIFIED ERROR OCCURRED. THE DOCTOR OR THE TECHNICIANS COULD NOT REMEMBER THE ERROR CODE. TO BYPASS THE ERROR THE DOCTOR MOVED THE FIBER CABLE FOR THE SLIT LAMP AND INSTALLED IT IN THE BIO PORT ON THE DUAL DELIVERY BOX. WHEN THE FIBER CABLE WAS SWAPPED THE DOCTOR WAS ABLE TO USE THE SLIT LAMP BUT THE PROTECTIVE FILTERS DID NOT WORK. THE DOCTOR WAS ABLE TO COMPLETE THE TREATMENT ON THE PATIENT, BUT THE PROTECTIVE FILTERS DO NOT MOVE WHEN THE DUAL DELIVERY BOX IS IN BIO MODE AS THE BIO HAS ITS OWN PERMANENT FILTERS AND THE SLIT LAMP PROTECTIVE FILTER DOES NOT FUNCTION IN THE BIO MODE. TO PREVENT VIEWING THE TREATMENT BEAM DIRECTLY THE DOCTOR PUT ON SAFETY GOGGLES TO PREVENT FLASHBACK. AS PER THE FSE'S ASSESSMENT, THE LASER SYSTEM WORKED AS IT WAS DESIGNED. FLASHBACK OCCURRED DUE TO THE LASER BEING USED OUT OF ITS DESIGNED CONFIGURATION. THE DOCTOR WAS ABLE TO USE THE SLIT LAMP DELIVERY BUT THE PROTECTIVE FILTERS DID NOT WORK. THE SL FIBER WAS CONNECTED TO THE BIO PORT ON THE DUAL DELIVERY BOX. THIS SITUATION WOULD NOT ACTIVATE THE PROTECTIVE FILTER FOR THE SL WHEN THE FOOTSWITCH IS PRESSED. SLIT LAMP DELIVERY UNITS SUCH AS NIDEK SL-1600 CAN BE CONNECTED ONLY TO CH1 OF THE DUAL DELIVERY UNIT AND NEVER CONNECTED TO CH2 ACCORDING TO THE OPERATORS MANUAL. AS A PRECAUTIONARY MEASURE, FSE ADVISED THE MANAGER TO INFORM THE STAFF THAT THE FIBER CABLE IS NOT TO BE SWITCHED OR REMOVED. WHEN AN ERROR OCCURS WITH THE LASER, THE STAFF IS TO CONTACT NIDEK DIRECTLY AND THE PROPER TECHNICAL ADVICE CAN BE GIVEN AT THAT TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2019 NIDEK INC. CUSTOMER SERVICE RECEIVED A TELEPHONE CALL FROM A CUSTOMER TO REPORT THAT THE PROTECTIVE FILTER ON THEIR GREEN LASER, GYC-1000 SERIAL NUMBER (B)(4) WOULD NOT COME DOWN. THE CUSTOMER REQUESTED ON-SITE SERVICE. WHILE PERFORMING THE DEVICE EVALUATION IN THE FOLLOWING WEEK, DOCTOR (B)(6) INFORMED NIDEK INC. FIELD SERVICE ENGINEER (FSE) OF EXPERIENCING FLASHBACK ISSUE ON (B)(6) 2019. THERE WAS NO INJURY REPORTED BY THE CUSTOMER FACILITY. NIDEK INC. HAS CONTACTED THE DOCTOR AND IS AWAITING INFORMATION FROM THE CUSTOMER FACILITY WITH RESPECT TO THE DOCTOR'S FLASHBACK EXPERIENCE. A SUPPLEMENTAL FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INFORMATION BECOMES AVAILABLE. THERE WAS NO DEVICE MALFUNCTION IDENTIFIED ON THE GREEN LASER BY THE FSE BUT NIDEK INC. CONSIDERS FLASHBACK ISSUE ON GYC-1000 AS A REPORTABLE EVENT AS THE GREEN LASER HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO OCCUR. THE GREEN LASER PHOTOCOAGULATOR SYSTEM GYC-1000 IS AN OPHTHALMOLOGICAL PHOTOCOAGULATION SYSTEM USING A SOLID STATE LASER (GREEN LASER BEAM) WITH A WAVELENGTH OF 532NM. LIKE CONVENTIONAL LASER PHOTOCOAGULATION SYSTEMS, THIS SYSTEM IS USED IN OPHTHALMIC SURGICAL PROCEDURES, INCLUDING RETINAL AND MACULAR PHOTOCOAGULATION, IRIDOTOMY AND TRABECULOPLASTY. THE GYC-1000 CAN BE USED WITH VARIOUS KINDS OF DELIVERY UNITS, SUCH AS SLIT LAMP OR BINOCULAR INDIRECT OPHTHALMOSCOPE. EACH DELIVERY UNIT IS PROVIDED WITH A PROTECTIVE FILTER TO PROTECT THE OPERATOR'S EYES FORM THE REFLECTION OF THE GREEN LASER BEAM. THIS PROTECTIVE FILTER IS INSERTED INTO THE OBSERVATION OPTICAL PATH ONLY WHEN THE GREEN LASER BEAM IS EMITTED. IF THE FILTER IS NOT SET IN THE OBSERVATION OPTICAL PATH WHEN THE FOOT SWITCH IS PRESSED FOR LASER BEAM EMISSION, THE LASER BEAM CANNOT BE EMITTED AND THE MAIN BODY WARNS THE OPERATOR WITH A BEEP SOUND AND AN ERROR MESSAGE INDICATION. TO PROTECT THE EYES OF PERSONNEL IN THE OPERATING ROOM, IT IS ADVISED TO INSTRUCT THEM TO WEAR RECOMMENDED LASER GOGGLES (OR THE EQUIVALENT) BEFORE THE OPERATION AND NOT LOOK AT THE GREEN LASER BEAM DIRECTLY DURING THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198985 GYC-1000 GREEN LASER PHOTOCOAGULATOR SYSTEM HQF NIDEK. CO. LTD. GYC-1000

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR