BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 7481640 · Received May 2, 2018

    Report

    Report Number
    0002936921-2018-00006
    Event Type
    Malfunction
    Date Received
    May 2, 2018
    Date of Event
    April 3, 2018
    Report Date
    May 25, 2018
    Manufacturer
    NIDEK CO., LTD
    Product Code
    LXS
    PMA / PMN Number
    K893987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ON MAY 15, 2018, NIDEK INC'S MDR SPECIALIST CONTACTED THE CUSTOMER BY PHONE AND IN RESPONSE, IT WAS ACKNOWLEDGED THAT THE CONDITION OF THE FACILITY DOCTOR AND THE PATIENT INVOLVED WERE FINE AND ALSO, NO MEDICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION CAN BE VERIFIED UNDER FOLLOWING SECTIONS IN THIS FORM.

    Description of Event or Problem · 0

    PLEASE SEE THE INITIAL MDR SUBMITTED ON MAY 2, 2018.

    Additional Manufacturer Narrative · 1

    ON APRIL 5, 2018, THE DEVICE IN QUESTION WAS EVALUATED AT THE USER'S FACILITY BY A NIDEK INC. FIELD SERVICE ENGINEER (FSE). FSE MEASURED 56V AC FROM GROUND TO HEADREST AND BODY OF LASER. THE AC POWER CORD APPEARS TO HAVE BEEN STEPPED ON THE BASE OF THE ALCON TABLE. FSE REMOVED THE POWER CORD AND FOUND DAMAGE TO THE END. BAD ELECTRICAL GROUNDING ON AC POWER CORD AND FRAME OF TABLE FLOATING AT 56V AC. FSE REPLACED AC POWER CORD WITH FACILITY'S SPARE POWER CORD, AND TESTED VOLTAGE FROM ELECTRICAL GROUND TO LASER BODY TO CHINREST AND FOUND VOLTAGE MEASURED AT BELOW 50MVAC. LEAKAGE VOLTAGE WAS NOW WITHIN SPEC. NIDEK INC. DETERMINED THAT ROOT CAUSE OF THE CUSTOMER REPORTED ISSUE WAS DUE TO DAMAGED AC POWER CORD OF THE ALCON TABLE. THE LASER WAS PLACED ON UNGROUNDED NON-NIDEK PRODUCT (ALCON TABLE) WHICH CAUSED HIGH ELECTRICAL LEAKAGE VOLTAGE. THUS, THE ISSUE WAS NOT CAUSED BY A NIDEK INC PRODUCT. AFTER THE DEVICE EVALUATION, THE LASER IS NOW OPERATIONAL.

    Description of Event or Problem · 1

    ON (B)(6) 2018, NIDEK INC. RECEIVED A PHONE CALL FROM A CUSTOMER STATING THAT WHILE THE USER'S FACILITY DOCTOR WAS PERFORMING A PROCEDURE ON A PATIENT, AN ELECTROSTATIC SHOCK FELT TO THE RIGHT HAND OF THE DOCTOR AND AT THE SAME TIME, THE PATIENT ALSO FELT THE ELECTROSTATIC TO THE LEFT EYE. THE PROCEDURE WAS PAUSED AND WILL RESUME AFTER THE LASER EVALUATION. AT THIS TIME, NIDEK HAS NO ADDITIONAL INFORMATION OF DOCTOR AND PATIENT CONDITION BUT A SUPPLEMENTAL FOLLOW-UP WILL BE SUBMITTED ONCE BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323154 YC-1800 YAG LASER LXS NIDEK CO., LTD

    Patients

    Seq Age Sex Outcome Treatment
    1