BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 5371346 · Received January 15, 2016

    Report

    Report Number
    3002807715-2016-00005
    Event Type
    Malfunction
    Date Received
    January 15, 2016
    Date of Event
    December 18, 2015
    Report Date
    January 15, 2016
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    HQF
    PMA / PMN Number
    K893987
    Removal / Correction Number
    2936921-2/20/2015-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS TO PROVIDE DEVICE EVALUATION REPORT FOR YC-1800 SN: (B)(4). DEVICE WAS RETURNED BACK TO NIDEK ON 1/6/2016. THE DEVICE WAS EVALUATED BY NIDEK SERVICE ENGINEER (SE). FSE CHECKED AND VERIFIED LASER OUTPUT, FOCUS AND ALIGNMENT OF THE YAG/AIMING. NO FAILURE WAS FOUND. NIDEK CLINICAL SPECIALIST CONTACTED SALES REP TO GATHER ADDITIONAL INFORMATION REGARDING THE COMPLAINT. ON (B)(6) 2016 SALES REP INFORMED THAT SHE HAD CONTACTED CUSTOMER TO GATHER PATIENT INFORMATION, HOWEVER, CUSTOMER HAD REFUSED TO PROVIDE THAT INFORMATION. SALES REP ALSO INFORMED CLINICAL SPECIALIST THAT THE DOCTOR WAS USING CORRECT SETTINGS AT THE TIME OF SURGERY. CLINICAL SPECIALIST REVIEWED THE IN-SERVICE TRAINING CHECKLIST AND CONFIRMED THAT THE DOCTOR WAS TRAINED BY THE NIDEK SALES REP AT THE TIME OF INSTALLATION OF THE DEVICE. CLINICAL SPECIALIST ALSO REVIEWED INSPECTION RECORD AND CONFIRMED THAT THE DEVICE HAD PASSED THE INSPECTION THE TIME OF DELIVERY. AS A PRECAUTIONARY MEASURE NIDEK INC. REPLACED CUSTOMER'S UNIT WITH THE NEW YC-1800 SN: (B)(4). THE ISSUE HAS BEEN RESOLVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED BACK TO NIDEK INC. ON 01/06/2016. THE EVALUATION OF THE DEVICE IS IN PROCESS AND NOT COMPLETED AT THIS TIME. NIDEK REPRESENTATIVE HAD CONTACTED TO GATHER ADDITIONAL INFORMATION REGARDING THE PATIENTS WITHOUT SUCCESS. FOLLOW UP REPORT WILL BE SUBMITTED IF ANY NEW INFORMATION WILL BE AVAILABLE AT LATER DATE. 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 (B)(6) 2015. DURING SURGERY WITH YC-1800 SERIAL NUMBER (SN): (B)(4), DOCTOR NOTICED THAT THE AIMING BEAM IS DIM AND REFLECTING OF THE LENS CAUSING IT TO BE OUT OF FOCUS. DOCTOR ALSO OBSERVED PITTING IN THE LENS. HOWEVER, DOCTOR COULD COMPLETE THE SURGERY WITHOUT MAJOR CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28922 YC-1800 ND: YAG LASER HQF NIDEK CO., LTD. YC-1800

    Patients

    Seq Age Sex Outcome Treatment
    1