BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 4330082 · Received August 28, 2014

    Report

    Report Number
    3002807715-2014-00009
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    January 1, 2013
    Report Date
    March 12, 2013
    Manufacturer
    NIDEK CO., LTD
    Product Code
    LZS
    PMA / PMN Number
    K893987S
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS RETURNED TO NIDEK FOR EVALUATION. ON EVALUATION THE TECHNICAL ENGINEER FOUND OUT THE LASER WAS CAUSING THE UNEVEN LASER BURN MARKS ON THE POLAROID PAPER. THE BAD BURN MARK WAS DUE TO THE LOW ENERGY OUTPUT MEASURED WITH THE YAG ENERGY METER. THE ENERGY OUTPUT COULD NOT BE ADJUSTED SO THE LASER HEAD WAS REPLACED BY THE TECH ENGINEERS. THE UNIT WAS THEN EVALUATED AND CONFIRMED THAT IT HAS BEEN OPERATIONAL. NIDEK HAVE NOT RECEIVED ANY COMPLAINTS OR INJURY RELATED TO THE DEVICE TO DATE. NIDEK CONTACTED THE CUSTOMER AND CONFIRMED THAT THERE WAS NO INJURY TO THE PATIENT ASSOCIATED TO THE EVENT. IF ADDITIONAL SIGNIFICANT INFO IS RECEIVED AT A LATER DATE, A F/U REPORT WILL BE SUBMITTED. NIDEK INC. CONSIDERS IT A REPORTABLE EVENT AS THE DEVICE HAS MALFUNCTIONED AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    NIDEK INC RECEIVED A COMPLAINT FROM A CUSTOMER ON (B)(6) 2013. DOCTOR REPORTED ABOUT PITTING OF LENSES WHILE USING YC-1800 S/N-(B)(4). THE DOCTOR MENTIONED THAT ENERGY WAS SET AT LMJ AND THE FOCUS SHIFT WAS AT 250-500UM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525769 YC-1800 ND: YAG LASER LZS NIDEK CO., LTD YC-1800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK