BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 7051541 · Received November 21, 2017

    Report

    Report Number
    0002936921-2017-00026
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Date of Event
    September 1, 2017
    Report Date
    January 22, 2018
    Manufacturer
    NIDEK CO., LTD
    Product Code
    LXS
    PMA / PMN Number
    K893987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ·ON (B)(6) 2017, A NIDEK INC FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE IN QUESTION AT THE USER'S FACILITY AND VERIFIED THE AIMING BEAM WAS OUT OF ALIGNMENT AND THE ENERGY WAS LOW. ·THE MAXIMUM ENERGY OUTPUT WAS 8.1 MJ, SHOULD BE AT LEAST 10.1 MJ, ENERGY WAS OUT OF SPECIFICATION. ·FSE REPLACED THE ENERGY CONTROL ASSEMBLY THAT INCLUDES THE BAD HALF LAMDA PLATE. ·FSE CALIBRATED PFN VOLTAGE (340 VDC), CLEANED OCULARS, OBJECTIVE LENS, OPTICS, AND ILLUMINATION STAGE. ALIGNED AIMING BEAM TO BEAM COINCIDENCE. ADJUSTED MIN. AND MAX. ENERGY CONTROL ASSY. CALIBRATED ENERGY READINGS TO DISPLAY. ADJUSTED TRACK ON BASE. FOCUS SHIFT 0-500 UM CHECKED OK. ALL ENERGY LEVELS ARE NOW IN SPECS. PLASMA DISCHARGE WAS 3.9 MJ. MAXIMUM ENERGY NOW READS AT 11.2 MJ (WITHIN SPEC.). TESTED AND INSPECTED LASER. PERFORMED NUMEROUS TEST SHOTS AND COMPLETE OPERATIONAL CHECK. ·THE DEVICE WAS FUNCTIONING PROPERLY AT ALL SETTINGS. ·IN CONCLUSION, NIDEK INC HAS DETERMINED THAT THE PROBABLE CAUSE OF THE CUSTOMER'S COMPLAINT ISSUE WAS DUE TO A DEFECTIVE ENERGY CONTROL ASSEMBLY. ACCORDING TO FSE, NORMAL WEAR AND TEAR CAUSED THE FAULTY COMPONENT TO MALFUNCTION. DEFECTIVE ENERGY CONTROL ASSEMBLY ON THE YAG LASER IS A KNOWN ISSUE AND CAPA (B)(4) WAS INITIATED AND THE INVESTIGATION IS ON-GOING. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THUS, THE DEVICE FUNCTIONS PROPERLY AT ALL SETTINGS, AFTER THE ENERGY CONTROL ASSEMBLY WAS REPLACED.

    Additional Manufacturer Narrative · 1

    INITIAL MDR SUBMISSION WAS POINTED TO (B)(4) FOR FOLLOW-UP INVESTIGATION, HOWEVER AFTER FURTHER REVIEW, NIDEK HAS LEARNED THAT THE YAG LASER'S AIMING BEAM OUT OF ALIGNMENT/FOCUS IS A KNOWN ISSUE AND BEING ADDRESSED UNDER (B)(4). AS PER CAPA IMPLEMENTATION, ACTIONS HAS BEEN TAKEN TO INFORM/NOTIFY EXISTING CUSTOMERS ON OBTAINING PREVENTIVE MAINTENANCE ON THEIR UNITS ONCE (1X) A YEAR TO MAINTAIN THE PRODUCT'S OVERALL PERFORMANCE AND RECOMMEDATION TO RETRAIN/TRAIN CUSTOMERS ON THE STANDARD OPERATION OF THE (B)(4). PLEASE NOTE THAT ON JANUARY 18, 2018, MDR SPECIALIST SPOKE WITH THE USER FACILITY DOCTOR AND HAS CONFIRMED THAT THE PATIENT INVOLVED WAS IN NO HARM AND WAS DOING FINE AFTER THE SURGERY. THE DOCTOR STATED THAT THE ENERGY OF THE LASER WAS ADJUSTED LOWER AND CHANGED THE FOCUS SETTINGS TO ACCOMPLISH THE SURGERY. AND ALSO, NO ADDITIONAL SURGERIES WERE PERFORMED TILL THE LASER WAS FIXED.

    Description of Event or Problem · 1

    ON (B)(6) 2017, NIDEK INC. CUSTOMER SERVICE RECEIVED A PHONE CALL FROM A CUSTOMER THAT THE AIMING BEAM WAS OUT OF ALIGNMENT ON THEIR YAG LASER YC-1800 SERIAL (B)(4). OUR NIDEK FIELD SERVICE ENGINEER CALLED THE CUSTOMER AND LEARNED THAT THE DEVICE ALSO WAS HAVING LOW ENERGY AND PITTING LENSES. THERE WAS NO SERIOUS ADVERSE EVENTS REPORTED FROM (B)(6) CLINIC FACILITY BUT NIDEK INC. CONSIDERS PITTING LENS ISSUE ON YC-1800 A REPORTABLE EVENT AS THE YAG LASER HAD MALFUNCTIONED AND 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
    828720 YC-1800 YAG LASER LXS NIDEK CO., LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability