BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 4921046 · Received July 15, 2015

    Report

    Report Number
    3002807715-2015-00034
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    January 1, 2015
    Report Date
    June 16, 2015
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    LXS
    PMA / PMN Number
    K893987
    Removal / Correction Number
    2936921-2/20/2015-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE HAS NOT BEEN RETURNED TO NIDEK AND HAS NOT EVALUATED SO THE RESULTS OF EVALUATION ARE NOT AVAILABLE AT THIS TIME. NIDEK CUSTOMER SERVICE MANAGER CONTACTED CUSTOMER TO GATHER ADDITIONAL INFORMATION REGARDING THE COMPLAINT. CUSTOMER DID NOT PROVIDE ANY ADDITIONAL DETAILS REGARDING THE DATE OF OCCURRENCE, NUMBER OF PATIENTS AND AGE/GENDER OF PATIENTS. NIDEK REQUESTED CUSTOMER TO DO SERVICE AND EVALUATION OF THE DEVICE. DOCTOR REFUSED TO PERFORM SERVICE AT THIS TIME. HOWEVER NIDEK WILL DO THE FIELD SERVICE FOR THIS DEVICE AT LATER DATE. IF ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED AT A LATER DATE, A FOLLOW-UP REPORT WILL BE SUBMITTED. NIDEK WILL BE SUBMITTING ONE MDR FOR THIS COMPLAINT AS NUMBER OF THE EVENTS OCCURRED COULD NOT BE CONFIRMED. 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 FROM A CUSTOMER ON 06/16/2015. NIDEK RECALL TEAM CONTACTED THE CUSTOMER REGARDING YC-1800 RECALL TEAM CONTACTED THE CUSTOMER REGARDING YC-1800 RECALL THAT TIME TECHNICIAN REPORTED THAT DOCTOR DOES HAVE PITTING LENS OCCASIONALLY DURING THE USE OF LASER YC-1800 SN:(B)(4). NO OTHER INFORMATION WAS PROVIDED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460508 YC-1800 ND:YAG LASER LXS NIDEK CO., LTD. YC-1800

    Patients

    Seq Age Sex Outcome Treatment
    1