BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 5115050 · Received September 30, 2015

    Report

    Report Number
    3002807715-2015-00047
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Date of Event
    July 1, 2015
    Report Date
    July 21, 2015
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    LXS
    PMA / PMN Number
    K893987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE NIDEK HOWEVER THE DEVICE WAS EVALUATED AT THE FILED BY THE FIELD SERVICE ENGINEER (FSE). THE DEVICE WAS TESTED AND INSPECTED FOR PROPER OPERATION. AIMING BEAM OUT OF FOCUS ISSUE COULD NOT BE DUPLICATED. THE AIMING BEAM FOCUS WAS TESTED FOR PROPER FUNCTIONING AND NO PROBLEM WAS FOUND. FSE ALSO DISCUSSED THE FOCUS ISSUE WITH THE DOCTOR AND SUGGESTED TO USE NEW ABRAHAM LENS WITH THE FOCUS SHIFT SETTING OF 250 INSTEAD OF 450 FOCUS SHIFT. AS PER OPERATORS MANUAL IT IS RECOMMENDED THAT DOCTOR SHOULD USE ABRAHAM LENS DURING SURGERY. (REFERENCE: OPHTHALMIC YAG LASER SYSTEM YC-1800 OPERATOR'S MANUAL; 4.4 PREPARING FOR TREATMENT; 12.CAUTION). FAILURE TO USE CONTACT LENS COULD CAUSE FOCUS ISSUE AS THE USE OF CONTACT LENS FACILITATES ACCURATE FOCUSING. (REFERENCE: HTTP://WWW.AAO.ORG/MUNNERLYN-LASER-SURGERY-CENTER/NDYAGLASER-POSTERIOR-CAPSULOTOMY-3). ADDITIONALLY FSE ALSO TESTED THE DEVICE FOR LOW POWER ISSUE. THE LOW POWER ISSUE WAS DUPLICATED AND VERIFIED BY THE FSE. SERVICE WAS PERFORMED AND POWER HAS BEEN ADJUSTED ACCORDING TO SPECIFICATIONS. THE SYSTEM WAS CALIBRATED. HOWEVER LOW POWER ISSUE DOES NOT HAS A POTENTIAL TO CAUSE AN ADVERSE EVENT EVEN IF THE ISSUE REOCCURS. (REFERENCE: OPERATORS MANUAL: 2.SAFETY AND PRECAUTIONS; 2.3 USE; CAUTION) NIDEK CONSIDERS THIS FAILURE MODE AS A REPORTABLE EVENT AS THE DEVICE HAS MALFUNCTIONED AND THE RECURRENCE OF THE FOCUS ISSUE HAS POTENTIAL TO CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    NIDEK INC. RECEIVED A COMPLAINT FROM A CUSTOMER ON (B)(6) 2015. CUSTOMER REPORTED THAT DURING THE USE OF YC-1800 SN: (B)(4) DOCTOR NOTICED THAT THE AIMING BEAM WAS OUT OF FOCUS. DOCTOR ALSO OBSERVED LOW POWER IN THE LASER. THE ISSUE WAS OBSERVED DURING THE TESTING OF THE DEVICE AND NO PATIENT WAS AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645315 YC-1800 ND : YAG LASER LXS NIDEK CO., LTD. YC-1800

    Patients

    Seq Age Sex Outcome Treatment
    1