BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-200

    MDR report key: 12465408 · Received September 13, 2021

    Report

    Report Number
    0002936921-2021-00004
    Event Type
    Malfunction
    Date Received
    September 13, 2021
    Date of Event
    August 27, 2021
    Report Date
    September 13, 2021
    Manufacturer
    NIDEK CO. LTD.
    Product Code
    HQF
    UDI-DI
    04987669101452
    PMA / PMN Number
    K203130
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ON 09/02/2021, NIDEK INC FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE. THE REPORTED ISSUE WAS NOT DUPLICATED. FSE TESTED LASER FOCUS AND FOCUS SHIFT, AND FOUND BOTH WITHIN SPECIFICATION. TESTED LASER ENERGY AND FOUND ENERGY WITHIN SPECIFICATION. 10MJ=10MJ. TESTED LASER SLIT ILLUMINATION AND FOUND IT WITHIN SPECIFICATION. THE SYSTEM IS OPERATIONAL. THE ROOT CAUSE OF THE ISSUE IS INCONCLUSIVE. THE REPORTED ISSUE WAS NOT DUPLICATED.

    Description of Event or Problem · 0

    ON (B)(6) 2021, NIDEK INC CUSTOMER REPRESENTATIVE RECEIVED AN EMAIL FROM THE CUSTOMER TO REPORT THAT THE DOCTOR SAW PITTING ON IOL BUT PUSHED THE LASER FORWARD TO STOP IT FROM HAPPENING. THE DOCTOR REPORTS THAT IF FOCUSED BEHIND THE CAPSULE WITH THE AIMING BEAMS SPLIT, IT DOES FINE. THE DOCTOR INFORMED NIDEK INC THAT THE PATIENT IS FINE, PITTING WAS INFERIOR TO UNDILATED PUPIL AND WILL NOT INTERFERE WITH VISION. PATIENT WILL NOT HAVE ANY ADVERSE EFFECTS. NIDEK INC CONSIDERS THIS ISSUE ON YC-200 AS A REPORTABLE EVENT AS AN UNDESIRABLE CONDITION OCCURRED WHILE USING THE DEVICE. TECHNICAL BACKGROUND: THE OPHTHALMIC YAG LASER SYSTEM YC-200 CONSISTS OF A SLIT LAMP AND THE YAG LASER AND IS INDICATED FOR THE PERFORMANCE OF POSTERIOR CAPSULOTOMY, PUPILLARY MEMBRANECTOMY, IRIDOTOMY (HOLE IN THE IRIS) AND SELECTIVE LASER TRABECULOPLASTY. THIS DEVICE USES PASSIVE Q-SWITCHING FOR LASER OSCILLATION. WITH PASSIVE Q-SWITCHING, THE DEVICE FIRST ACCUMULATES SUFFICIENT ENERGY WITHIN THE LASER CAVITY THEN EMITS LASER PULSES OF HIGH PEAK POWER FOR EXTREMELY SHORT DURATIONS BY USE OF THE Q-SWITCHED OPTICAL ELEMENT WHICH CHANGES BETWEEN TRANSPARENT AND OPAQUE ACCORDING TO THE ACCUMULATION OF ENERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363197 YC-200 YAG LASER HQF NIDEK CO. LTD. 04987669101452

    Patients

    Seq Age Sex Outcome Treatment
    1 Other