BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 4289166 · Received November 18, 2014

    Report

    Report Number
    3002807715-2014-00033
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 4, 2014
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    LZS
    PMA / PMN Number
    K893987S
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. DOCTOR REPORTED TO FSE THAT THE ILLUMINATION WAS NOT BRIGHT ENOUGH; JOYSTICK MOVEMENT WAS NOT SMOOTH IN ALL DIRECTIONS, AND ALSO HE HAD TO SLIGHTLY ADJUST THE FOCUS TO ANTERIOR DIRECTION TO GET DESIRED RESULTS WITH SOME PROCEDURES. FSE PERFORMED THE AUTO CALIBRATION. THE TREATMENT OUTPUT ENERGIES WERE CHECKED AND WERE WITHIN SPECIFICATIONS. ILLUMINATION WAS ALIGNED. FSE NOTICED THAT THE OCULARS AND OBJECTIVE LENS WAS SMEARED. FSE CLEANED THE OCULARS, OBJECTIVE LENS, ILLUMINATION STAGE, TEFLON BASE PAD, GEAR WHEELS / TRACKS ON BASE, AND EXTERIOR OF THE UNIT. FSE SUGGESTED TO THE DOCTOR TO ADJUST OFFSET TO 125 OR 250 POSTERIOR, INSTEAD OF SETTING FOR 0, AND ADJUST FOCUS SLIGHTLY ANTERIOR. THE SYSTEM HAS BEEN OPERATIONAL. THE SYSTEM HAS BEEN EVALUATED AND NO FAILURE WAS FOUND. FSE SUGGESTED THAT THE PROBLEM COULD HAVE OCCURRED DUE TO THE SMEARING OF THE LENS. NIDEK CONTACTED THE CLINICAL MANAGER AND CONFIRMED THAT THERE WAS NO INJURY TO THE PATIENT. THE SYSTEM HAS BEEN OPERATIONAL. 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 FROM THE CUSTOMER ON (B)(6) 2014. DOCTOR REPORTED THAT DURING THE SURGERY WITH YC-1800; SN (B)(4), HE NOTICED THAT THE LASER DISRUPTION IN THE PATIENT'S EYE OCCURRED IN A DIFFERENT PLACE THAN WHERE HE WAS AIMING WHEN THE AIMING BEAM WAS FOCUSED AND LASER WAS FIRED. NO PATIENT INJURY WAS REPORTED BUT THE DOCTOR WAS UNHAPPY WITH THE TREATMENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746954 YC-1800 ND: YAG LASER LZS NIDEK CO., LTD. YC-1800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK