BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 4080821 · Received August 22, 2014

    Report

    Report Number
    3002807715-2014-00006
    Event Type
    Malfunction
    Date Received
    August 22, 2014
    Date of Event
    January 1, 2013
    Report Date
    July 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
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS NOT RETURNED TO NIDEK FOR EVALUATION. HOWEVER, A NIDEK FIELD SERVICE ENGINEER (FSE) HAD CONDUCTED AN ON SITE EVALUATION AND DETERMINED THAT THE TREATMENT OUTPUT ENERGIES WERE HIGHER THAN THE DISPLAY SCREEN AND HAD SUBSEQUENTLY READJUSTED TO MEET SPECIFICATIONS. FSE ALSO FOUND THE FOCUS SHIFT POINT WAS OFF AND ADJUSTED THE FOCUS SHIFT. THE SYSTEM HAS BEEN WORKING APPROPRIATELY TO DATE. NIDEK HAVE NOT RECEIVED ANY COMPLAINTS OR INJURY RELATED TO THE DEVICE TO DATE. ON (B)(4) 2014, NIDEK CLINICAL SPECIALIST MADE ATTEMPTS TO CONTACT THE ASSIGNED FSE VIA PHONE AND E-MAIL TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WITHOUT SUCCESS. IF ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED AT A LATER DATE, A FOLLOW-UP REPORT WILL BE SUBMITTED. NIDEK CONSIDERS THIS FAILURE MODE 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 ((B)(4)) FROM A CUSTOMER. THE USER FACILITY REPORTED THAT WHILE USING YC-1800; (B)(4) A CLEAR IMAGE WAS OBSERVED FROM SLIT LAMP BUT THE IMAGE FORM SIDE SCOPE WAS NOT CLEAR. CUSTOMER ALSO MENTIONED THAT THE FOCUS SHIFT WAS OFF CAUSING THE PITTING LENSES. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508223 YC-1800 ND: YAG LASER LZS NIDEK CO., LTD YC-1800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK