BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 4092408 · Received September 5, 2014

    Report

    Report Number
    3002807715-2014-00011
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    January 1, 2013
    Report Date
    August 7, 2013
    Manufacturer
    NIDEK CO. LTD
    Product Code
    LZS
    PMA / PMN Number
    K893987S
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    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. THE TREATMENT OUTPUT ENERGIES WERE CHECKED AND WERE WITHIN SPECIFICATIONS. THE FSE CHECKED THE FOCUS SHIFT AND WAS WITHIN SPECIFICATIONS. AUTO CALIBRATION WAS PERFORMED. NO FAILURE WAS FOUND. THE SYSTEM HAS BEEN WORKING APPROPRIATELY TO DATE. NIDEK HAVE NOT RECEIVED ANY COMPLAINTS OR INJURY RELATED TO THE DEVICE TO DATE. NIDEK MADE ATTEMPT TO CONTACT THE CUSTOMER 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 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 RECEIVED A COMPLAINT ON (B)(6) 2013 FROM THE CUSTOMER FOR YC-1800; S/N (B)(4). DOCTOR REPORTED THAT WHILE USING YC-1800, THE IMAGE WAS NOT CLEAR AND THE AIMING BEAM WAS SMALL. DOCTOR HAD ADJUSTED THE FOCUS SHIFT TO ANTERIOR AND POSTERIOR, BUT STILL COULD NOT SEE CLEAR IMAGE. DOCTOR HAS ALSO NOTICED OF PITTING OF LENS EVEN WITH THE SUGGESTED OFFSET AND POWER PARAMETERS (POSTERIOR OFFSET 200 MICRONS/1.8-2.0MJ).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546046 YC-1800 ND:YAG LASER LZS NIDEK CO. LTD YC-1800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK