BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 4844599 · Received June 11, 2015

    Report

    Report Number
    3002807715-2015-00023
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 15, 2015
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    LXS
    PMA / PMN Number
    K893987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS NOT RETURNED BACK TO NIDEK. NIDEK FIELD SVC ENGINEER (FSE) CONTACTED THE FACILITY AND PHONE SUPPORT WAS PROVIDED. THE ISSUE WAS RESOLVED OVER THE PHONE. FSE VERIFIED THE COMPLAINT OVER THE PHONE. FSE CONFIRMED WITH THE TECH THAT DURING INSTALLATION OF THE BINOCULARS TECH PULLED ON THE EYE PIECES WHICH RESULTED THE MISALIGNMENT OF THE EYE PIECES AND THE BINOCULARS AND THUS CAUSED THE AIMING OUT OF FOCUS. FSE INSTRUCTED TECH TO ALIGN THE EYEPIECES AND THE ISSUE WAS RESOLVED OVER THE PHONE. AT THIS TIME NO PT HAS BEEN AFFECTED AND HENCE NO PT INFO IS AVAILABLE. 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 OF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    NIDEK INC. REC'D A COMPLAINT FROM A CUSTOMER ON (B)(6) 2015. CUSTOMER REPORTED THAT DURING THE USE OF YC-1800 SN (B)(4). AIMING BEAM WAS OUT OF FOCUS WHEN THE OCULARS WERE SET AT THE LOWER MAGNIFICATION. AIMING BEAM WAS IN FOCUS WHEN THE OCULARS WERE SET AT A HIGHER MAGNIFICATION BUT THE CAPSULE WAS NOT VISIBLE. HOWEVER DOCTOR WANTED TO USE THE MAGNIFICATION AT A HIGHER SETTINGS. EVEN THOUGH DOCTOR COULD TREAT THE PTS WITHOUT INCIDENT OR ANY INJURY AT THIS TIME HE REQUESTED NIDEK TO CHECK THE LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380870 YC-1800 ND:YAG LASER LXS NIDEK CO., LTD. YC-1800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK