BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EC-5000 QUEST

    MDR report key: 8839370 · Received July 29, 2019

    Report

    Report Number
    0002936921-2019-00008
    Event Type
    Malfunction
    Date Received
    July 29, 2019
    Date of Event
    July 1, 2019
    Report Date
    July 29, 2019
    Manufacturer
    NIDEK INC.
    Product Code
    LZS
    PMA / PMN Number
    P970053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NIDEK EXCIMER LASER SYSTEM, MODEL QUEST, USES MIXTURES OF FLUORINE AND HELIUM GASES; ARGON, HELIUM AND NEON GASES; TO GENERATE THE EXCIMER LASING ACTION. IN THESE GASES; FLUORINE DEMANDS SPECIAL CAUTIONS, BECAUSE OF ITS HIGHLY TOXIC AND DANGEROUS NATURE. IN A DANGEROUS CONDITION FROM GAS LEA OR OTHER REASONS, NIDEK RECOMMENDS STOP USAGE OF THE SYSTEM. THEN MOVE THE GAS TO A SAFE PLACE OR RELEASE IT IN THE AIR, AND EVACUATE THE PEOPLE IN NEIGHBORING AREAS. AS A SAFETY DEVICE AGAINST THE LEAKAGE OF FLUORINE (F2) GAS FROM THE MAIN BODY, THE INSIDE OF THE SYSTEM IS ALWAYS VENTILATED. WHEN THE LASER GAS IS EXHAUSTED FROM THE MAIN BODY, THE BUILT-IN HALOGEN FILTER DECREASES THE CONCENTRATION OF THE GAS TO A SAFE LEVEL. ON JULY 2, 2019 NIDEK INC. FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE AT THE USER FACILITY AND OBSERVED THE OVER PRESSURE VALVE OPEN AND PREMIX TANK EMPTY. THE HELIUM TANK EMPTY VALVE FOR THE TANK WAS ALL THE WAY ON. THE BYPASS VALVE WAS NOT ALL THE WAY CLOSED. LASER LOG SHOWED WARNING 10 (INDICATING NO GAS FLOW FROM PREMIX TANK) AND WARNING 7 (INDICATING PREMIX LEAK IS DETECTED BY F2 SENSOR). THE RECOMMENDED SETTING FOR SECONDARY GAS PRESSURE FOR THE PREMIXED GAS IS 0.4 MPA. HOWEVER, PREMIX PRESSURE REGULATOR HAS 0.04 MPA SHOWING IF REGULATOR CONTROL IS TURNED CLOCKWISE TO INCREASE THE PRESSURE. WHEN THE REGULATOR CONTROL IS TURNED COUNTER CLOCKWISE THE PRESSURE DROPS TO ZERO INDICATING A LEAK THROUGH THE OVER PRESSURE VALVE. THIS WAS VERIFIED BY CHECKING FOR FLOW OF FILTERED GAS FROM HALOGEN FILTER EXIT PORT ON BOTTOM OF FILTER. FSE REPLACED THE OVER PRESSURE VALVE AND TESTED SYSTEM FOR LEAKS. FSE RETURNED TO THE CUSTOMER SITE ON 7/24/2019 TO REPLACE THE NEW GAS TANKS AND TO PRESSURE TEST THE SYSTEM AT FULL PRESSURE. PRESSURE TEST WAS DONE AFTER INSTALL OF NEW TANKS AND NO LEAKS WERE FOUND. FSE INSTALLED DOUBLE PRESSURE VALVES, PERFORMED TWO NEW FILLS AND ENSURED NO LEAKS OCCURRED. THE LASER SYSTEM WAS CALIBRATED: NORMAL 161 MJ AT 25.2KV; FLEX 154MJ AT 24.7KV; HYPER IS 46 SECONDS WITH +25 OFFSET. THE CUSTOMER REPORTED OF A SIMILAR ISSUE ON 24-OCT-2017. NIDEK PROVIDED ADDITIONAL TRAINING TO THE TECHNICIANS ON OPERATION OF THE QUEST LASER ON 31-OCT-2017. IT WAS FOUND THAT THE CUSTOMER DOESN'T USE THE LASER ENOUGH TO RETAIN THEIR TRAININGS. AS A PREVENTIVE MEASURE, FSE RETRAINED THE TECHNICIANS ON HOW TO DO A NEW FILL AND LEFT WRITTEN INFORMATION FOR THEIR USE TO SHOW THE PARTICULAR VALVES TO TOUCH AND THOSE NOT TO TOUCH. THESE INSTRUCTIONS WERE PLACED ON THE DOOR OF THE GAS CABINET. THE CABINET WAS ALSO MARKED WITH THE GAUGE TO LOOK AT AND TO DIFFERENTIATE THE PREMIX TANK. THE SYSTEM WAS WORKING PROPERLY AND READY TO BE USED. NIDEK INC. DETERMINED THAT THE FULLY OPEN HELIUM TANK AND BYPASS VALVE CAUSED OVER PRESSURE CONDITION CAUSING A TRACE AMOUNT OF PREMIX GAS TO VENT THROUGH HALOGEN FILTER. THE CUSTOMER MISINTERPRETED THE HELIUM TANK VALVE WAS OFF HOWEVER IT WAS ALL THE WAY ON; THE HELIUM TANK VALVE WAS TURNED ALL THE WAY COUNTER CLOCKWISE AND WAS EXTREMELY TIGHT. THIS POTENTIALLY CONTRIBUTED TO THE DAMAGE OF OVER PRESSURE VALVE (CHECK VALVE) AS THE HELIUM TANK WAS LEFT OPEN THE DEVICE FUNCTIONS PROPERLY, AND NO GAS LEAK WAS DETECTED AFTER THE CHECK/LEAK VALVE COMPONENT WAS REPLACED.

    Description of Event or Problem · 1

    ON JULY 1, 2019, NIDEK INC. CUSTOMER SERVICE RECEIVED A TELEPHONE CALL FROM A CUSTOMER TO REPORT THAT THE PREMIX LEAK ALARM SOUNDED ON THEIR EXCIMER LASER, EC-5000 QUEST SERIAL # (B)(4), AND THE LASER SHOWED MESSAGE TO SHUT DOWN AND LEAVE THE ROOM. THERE WAS NO INJURY REPORTED HENCE NO PATIENT INFORMATION IS AVAILABLE. NIDEK EXCIMER LASER SYSTEM QUEST HAS THE SELF-CHECK FUNCTION. IF ANY ABNORMALITY IS FOUND IN THE SYSTEM, THE MONITOR DISPLAYS THE WARNING MESSAGE. IF ANY MESSAGE IS DISPLAYED ON THE MONITOR, THE OPERATOR IS RECOMMENDED TO TAKE THE COUNTERMEASURE ACCORDING TO THE INSTRUCTION. "WARNING NO. 7 : DETECT THE LEAKAGE OF FLUORINE GAS. GO AWAY FROM THIS ROOM." NIDEK INC. QA SPECIALIST CONTACTED THE TECHNICIAN AT THE CUSTOMER SITE ON JULY 2, 2019. ACCORDING TO THE TECHNICIAN, THE PREMIX ODOR WASN'T STRONG; THERE WAS TRACE AMOUNT OF GAS PRESENT. SHE IMMEDIATELY EVACUATED THE ROOM WHEN SHE SAW THE MESSAGE TO LEAVE THE ROOM AND CLOSED THE DOOR. SHORTLY LATER SHE ADVISED THE DOCTOR AND THEN CALLED NIDEK INC. FIELD SERVICE ENGINEER. FSE ADVISED THEM TO STAY AWAY FROM THE ODOR IN ORDER TO AVOID ANY INJURY AND CANCEL THE SURGERIES. THE TECHNICIAN IS FINE; THERE WERE NO SYMPTOMS OF EXPOSURE REPORTED. A NIDEK INC. FSE VISITED THE SITE ON JULY 2, 2019 TO IDENTIFY WHAT THE CAUSE OF THE LEAK. NIDEK INC. CONSIDERS GAS LEAK ISSUE ON EXCIMER LASER A REPORTABLE EVENT AS AN UNDESIRABLE CONDITION OCCURRED WHILE USING THE EC-5000 QUEST THAT HAS A POTENTIAL TO CAUSE, OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633032 EC-5000 QUEST NIDEK EXCIMER LASER QUEST LZS NIDEK INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1