BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 6140287 · Received December 1, 2016

    Report

    Report Number
    0002936921-2016-00003
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    November 8, 2016
    Report Date
    January 30, 2017
    Manufacturer
    NIDEK INCORPORATED
    Product Code
    HQF
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NIDEK INC. CONSIDERS PITTING LENS ISSUE ON YAG LASER A REPORTABLE EVENT AS THE YC-1800 HAD MALFUNCTIONED AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. DEVICE EVALUATION IN WORK PROCESS, A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE EVALUATION OF DEVICE IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT WAS TO PROVIDE THE DEVICE EVALUATION INFORMATION FOR THE INITIAL MDR REPORT SUBMITTED ON 11/08/2016. DEVICE WAS RETURNED TO NIDEK INC AND WAS EVALUATED BY AN IN-HOUSE NIDEK SERVICE ENGINEER (SE). SE TESTED AND VERIFIED LASER OUTPUT, FOCUS AND ALIGNMENT OF THE YAG/AIMING AND NO FAILURE FOUND. CONCLUDES THAT THE DEVICE WAS FUNCTIONING PROPERLY AND THE CUSTOMER'S COMPLAINT ISSUE WAS NOT CONFIRMED. BASED ON GATHERED DATA FROM CUSTOMER'S EMAIL TO A NIDEK MDR SPECIALIST, THE DEVICE SETTINGS WERE CHANGED PRIOR TO USE BUT ACCORDING TO SE, THE SETTINGS OBSERVED WERE WITHIN SPECIFICATION AND THAT THE DOCTOR WAS USING CORRECT SETTINGS AT THE TIME OF SURGERY. IN ADDITION, THE CUSTOMER MENTIONED THAT NO SURGICAL OR MEDICAL INTERVENTION NEEDED FOR THE PATIENT INVOLVED. PER IDAR RECORD, THE USER FACILITY HAD THE DEMO LASER SINCE AUGUST 2016 AND AS A PRECAUTIONARY MEASURE, NIDEK INC. REPLACED CUSTOMER'S UNIT WITH THE NEW YC-1800 SN: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2016, NIDEK INC. CUSTOMER SERVICE RECEIVED A TELEPHONE CALL A USER FACILITY TO REPORT THAT THE LASER WAS NOT AIMING TO THE CORRECT SPOT, IT WAS AIMING BEFORE OR BEHIND THE INTENDED AREA AND OUT OF 130 SHOTS, ONLY 10 WERE GOOD. THE CUSTOMER STATES THAT PITTING LENS WAS OBSERVED BUT NO PATIENT INJURY OCCURRED.

    Description of Event or Problem · 1

    SEE INITIAL MDR 0002936921-2016-00003 FOR DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788784 YC-1800 YAG LASER HQF NIDEK INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1