BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 6915805 · Received October 5, 2017

    Report

    Report Number
    0002936921-2017-00023
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    September 8, 2017
    Report Date
    November 22, 2017
    Manufacturer
    NIDEK CO.,LTD
    Product Code
    LXS
    PMA / PMN Number
    K893987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON SEPTEMBER 14, 2017, THE DEVICE WAS EVALUATED BY A NIDEK INC. FIELD SERVICE ENGINEER (FSE) AT THE USER'S FACILITY. FSE CHECKED ACTUAL ENERGY, FOUND DISPLAY HIGHER THAN ACTUAL ENERGY, DISPLAY READS AT 3.4MJ BUT THE ACTUAL ENERGY WAS AT 3MJ. FSE ADJUSTED THE DISPLAY TO MATCH THE ACTUAL ENERGY AND PERFORMED AUTO-CALIBRATION. AFTER CALIBRATION, FSE RE-CHECKED ACTUAL ENERGY, FOUND TO BE WITH-IN +/- 5% (AT SPEC.). FOCUS SHIFT 0 TO 500 MICRONS ANTERIOR AND POSTERIOR FOUND WITH-IN SPEC. LASER PROPERLY OPERATING ON ALL SETTINGS. ON OCTOBER 14, 2017, NIDEK INC RECEIVED A REPLIED EMAIL FROM THE CUSTOMER (DOCTOR): THE DOCTOR HAS CONFIRMED THAT THE AIMING BEAM WAS SET AT MODERATE ILLUMINATION WHEN THE PITTING LENS WAS OBSERVED AND THE PATIENT'S EYES SEEMED TO BE MONOFOCAL IOL. THE DOCTOR TRIED EVERYTHING TO COMPLETE THE SURGERY BY LOWERING THE ENERGY AND MOVING THE POSTERIOR OFFSET TO DIFFERENT LOCATIONS AND FORTUNATELY, THE PATIENT DID NOT NEED ANY MEDICAL OR SURGICAL INTERVENTION. THE DOCTOR ADDED THAT AS SOON AS THE SERVICE WAS COMPLETED, THE LASER WORKS WELL NOW. IN CONCLUSION, NIDEK INC DETERMINED THAT THE PROBABLE CAUSE OF THE CUSTOMER'S COMPLAINT ISSUE WAS DUE TO LASER IN NEED OF CALIBRATION. THUS, THE YAG LASER FUNCTIONS PROPERLY AT ALL SETTINGS AFTER CALIBRATION WAS COMPLETED.

    Additional Manufacturer Narrative · 1

    NIDEK INC. CONSIDERS PITTING LENS ISSUE ON YAG LASER A REPORTABLE EVENT AS THE YC-1800 HAD MALFUNCTIONED AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. DEVICE EVALUATION IS IN WORK PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE DEVICE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    REFER TO THE INITIAL MDR 0002936921-2017-00023 SUBMITTED ON 9/8/2017.

    Description of Event or Problem · 1

    ON (B)(4) 2017, NIDEK INC. CUSTOMER SERVICE RECEIVED A TELEPHONE CALL FROM A CUSTOMER TO REPORT THAT THE DOCTOR OBSERVED PITTING LENS DURING SURGICAL PROCEDURE. HOWEVER, THE USER'S FACILITY CLAIMED THAT THERE WAS NO SERIOUS ADVERSE EVENT IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695736 YC-1800 YAG LASER LXS NIDEK CO.,LTD

    Patients

    Seq Age Sex Outcome Treatment
    1