BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 8291219 · Received January 30, 2019

    Report

    Report Number
    0002936921-2019-00003
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Date of Event
    January 25, 2019
    Report Date
    January 30, 2019
    Manufacturer
    NIDEK CO., LTD
    Product Code
    LXS
    PMA / PMN Number
    K893987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY NIDEK SERVICE ENGINEER (SE) ON 01/25/2019. DEVICE WAS RETURNED TO NIDEK INC. FOR SERVICE SINCE THE CUSTOMER REPORTED OF THE LASER NOT FIRING CORRECTLY. SE TESTED THE DEVICE FOR PROPER OPERATION. THE LASER WOULDN'T FIRE CONSTANTLY. EVERY TIME THE YAG LASER BEAM IS EMITTED, AN ELECTRICAL BEEP SOUNDS AND PLASMA DISCHARGE OCCURS. AN AIR PLASMA DISCHARGE OCCURS IN 8 OUT OF 10 FIRINGS AT A STANDARD OF 5 MJ OR LESS. SE OBSERVED THE LASER WOULD NOT FIRE CONSTANTLY AND PLASMA DISCHARGE OCCURRED INTERMITTENTLY. SE FOUND THAT THE ACTUAL ENERGY OUTPUT WAS HIGH; 13.5MJ. CALIBRATION WAS OUT OF SPECIFICATIONS FOR YAG LASER BEAM. HENCE, SE CALIBRATED THE SYSTEM FOR YAG LASER BEAM MAXIMUM ENERGY OUTPUT AS DESCRIBED IN THE SERVICE MANUAL SECTION 7.6.1 MAXIMUM ENERGY OUTPUT. THEN LASER OUTPUT WAS VERIFIED TO BE WITHIN SPECIFICATIONS: 0.2MJ-11.5MJ. THE CUSTOMER REPORTED ISSUE WAS DUE TO THE DEVICE OUT OF CALIBRATION. DEVICE WAS TESTED AND VERIFIED FOR PROPER OPERATION. ADDITIONALLY, THE CHIN-REST GRIP WAS BROKEN AND MISSING TWO CHIN-REST PINS. HOWEVER, THE PARTS WERE NOT REPLACED BASED ON CUSTOMER'S DECISION. THE DEVICE WAS LAST SERVICED IN 9 SEPTEMBER 2018 FOR ROUTINE PREVENTIVE MAINTENANCE. THE PRESET DATA AND OUTPUT DISPLAY CALIBRATION WAS PERFORMED. THE ENERGIES WERE WITHIN SPECIFICATION: 1.0MJ-10.5 MJ. PER OPERATORS MANUAL IT IS RECOMMENDED TO PERFORM CALIBRATION OF POWER OUTPUT OF THE YAG LASER ONCE A YEAR. REFERENCE: 2.4 AFTER USE, MAINTENANCE, AND CHECKS; CAUTION, "TO ENSURE THE CONTINUED SAFE USE OF THE DEVICE, THE MANAGER OF THE DEVICE MUST MAKE SURE THAT MAINTENANCE, PREVENTIVE INSPECTION, AND LASER OUTPUT CALIBRATION ARE PERFORMED AT LEAST ONCE A YEAR."

    Description of Event or Problem · 1

    NIDEK INC. RECEIVED A COMPLAINT FROM CUSTOMER ON (B)(6) 2018 REPORTING THAT DURING THE USE OF YC-1800 SN: (B)(4); EVERY 2ND TO 3RD TIME THE LASER IS FIRED, IT SOUNDS LIKE IT'S FIRING, BUT NOT FIRING. HIGH ENERGY WAS IDENTIFIED DURING THE DEVICE EVALUATION BY NIDEK INC. SERVICE ENGINEER (SE) ON 01/25/2019. NO INJURY WAS REPORTED AT THAT TIME AND HENCE NO PATIENT INFORMATION IS AVAILABLE. NIDEK INC. CONSIDERS HIGH ENERGY ISSUE A REPORTABLE EVENT AS THE DEVICE HAS MALFUNCTIONED AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE ISSUE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83542 YC-1800 ND: YAG LASER LXS NIDEK CO., LTD YC-1800

    Patients

    Seq Age Sex Outcome Treatment
    1