BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-200

    MDR report key: 11935696 · Received June 3, 2021

    Report

    Report Number
    0002936921-2021-00002
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Report Date
    July 1, 2021
    Manufacturer
    NIDEK CO. LTD.
    Product Code
    HQF
    UDI-DI
    04987669101452
    PMA / PMN Number
    K203130
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ON 05/19/2021, NIDEK INC FIELD SERVICE ENGINEER (FSE) WENT ON THE CUSTOMER SITE. FSE TEST FIRED YAG LASER AND FOUND THAT THE ERROR MESSAGE "PLEASE WAIT" COMES UP AT RANDOM TIMES NO MATTER HOW FAST THE JOYSTICK BUTTON IS PRESSED. FSE FOUND LASER ENERGY WITHIN SPEC. 1.0MJ = 0.98MJ. FSE TESTED LASER CENTER AND FOCUS AND FOUND THEM TO BE WITHIN SPEC. NO ADJUSTMENTS WERE MADE TO NEW LASER. THE REPORTED UNIT S/N. (B)(6) WAS REPLACED WITH S/N. (B)(6). THE REPORTED UNIT S/N. (B)(6) WAS RETURNED TO NIDEK INC IN-HOUSE FOR FURTHER INSPECTION. ON 06/25/2021, NIDEK INC LEAD ENGINEERING TECHNICIAN TESTED AND INSPECTED THE SYSTEM. OBSERVED NORMAL WORKING CONDITION. CONFIRMED VARIATION OF FOCAL POINT, PROPER ENERGY OUTPUT 0.3MJ ~ 10MJ WITH BURST 2 AND 3 AS WELL, PROPER BURN PATTERN AND PLASMA, AND LASER FIRING NORMALLY. THE CAUSE OF CUSTOMER'S REPORTED PROBLEM "TAKES MORE SHOTS TO GET AN OPENING. ALSO PITTING IOL." IS INCONCLUSIVE. THE SYSTEM IS OPERATIONAL.

    Description of Event or Problem · 0

    PLEASE SEE THE INITIAL MDR SUBMITTED ON 03-JUN-2021.

    Additional Manufacturer Narrative · 1

    INITIAL DEVICE EVALUATION WAS PERFORMED ON (B)(6) 2021 BY NIDEK INC FIELD SERVICE ENGINEER (FSE) AT CUSTOMER SITE. LASER ENERGY AND FOCUS WERE WITHIN SPECIFICATION. NO PROBLEM FOUND. THE REPORTED UNIT S/N. (B)(4) WILL BE REPLACED WITH NEW UNIT S/N. (B)(4). THE UNIT S/N. (B)(4) WILL BE RETURNED IN-HOUSE FOR FURTHER INVESTIGATION. FOLLOW UP MDR WILL BE SUBMITTED ONCE IN-HOUSE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    ON (B)(6) 2021, NIDEK INC CUSTOMER SERVICE REPRESENTATIVE RECEIVED A TELEPHONE CALL FROM THE CUSTOMER TO REPORT THAT THE LASER IS TAKING MORE SHOTS TO GET AN OPENING, AND ALSO REPORTING THAT THE DOCTOR IS PITTING THE IOL. THE ISSUE OCCURRED WHILE USING THE YC-200 S PLUS DEVICE S/N. (B)(4) IN THE FACILITY'S LASER ROOM. ACCORDING TO THE DOCTOR: "WHEN WE DO YAG LASERS, WE FOCUS THE BEAM JUST A BIT POSTERIOR TO THE IOL. IF THE ENERGY HITS THE LENS DIRECTLY, IT WILL PIT IT. IT HAS MINIMAL IF ANY IMPACT ON THE PATIENTS VISION AND NOTHING IS DONE OR NEEDS TO BE DONE.". NIDEK INC. CONSIDERS PITTING LENS ISSUE A REPORTABLE EVENT AS IT IS AN UNDESIRABLE CONDITION AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE ISSUES WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832105 YC-200 YAG LASER HQF NIDEK CO. LTD. 04987669101452

    Patients

    Seq Age Sex Outcome Treatment
    1 Other