BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-200 S PLUS

    MDR report key: 14459584 · Received May 20, 2022

    Report

    Report Number
    0002936921-2022-00004
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    April 25, 2022
    Report Date
    May 19, 2022
    Manufacturer
    NIDEK CO. LTD.
    Product Code
    HQF
    UDI-DI
    04987669101452
    PMA / PMN Number
    K203130
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NIDEK INC. DETERMINED THAT THE CAUSE OF CUSTOMER REPORTED ISSUE "PITTING LENS" WAS INCONCLUSIVE. THE SYSTEM WAS TESTED AND INSPECTED. NIDEK INC FIELD SERVICE ENGINEER (FSE) VERIFIED THAT THE SYSTEM IS OPERATIONAL. THE REPORTED UNIT PASSED FINAL INSPECTION PER INSPECTION DISTRIBUTION ACCEPTANCE RECORD# (B)(4), AND INSTALLATION AND IN-SERVICE TRAINING WAS PERFORMED PROPERLY PER INSTALLATION/IN-SERVICE RECORD# (B)(4). THERE WAS NO SUPPORTING EVIDENCE TO POINT TO MACHINE, MAN, AND METHOD/PROCESS AND MATERIAL AS THE CAUSE OF THE REPORTED COMPLAINT ISSUE. AS A PRECAUTION, FSE INSTALLED FOOT PEDAL (PART NO. 17330-0012) AND REPLACED SLIDE PLATE (PART NO. YC020-M216). IN ADDITION, RG-093-2 YC-200/ YC-200 S PLUS QUICK REFERENCE GUIDE WILL BE SENT OUT TO THE CUSTOMER TO REMIND CUSTOMER OF SAFETY INFORMATION IN YC-200 OPERATOR'S MANUAL TO MITIGATE AGAINST POTENTIAL OCCURRENCE OF PITTING LENSES. DEVICE EVALUATION IS COMPLETED AND FSE VERIFIED THAT THE SYSTEM IS OPERATIONAL.

    Description of Event or Problem · 0

    ON (B)(6) 2022, NIDEK INC. SERVICE MANAGER RECEIVED A TELEPHONE CALL FROM NIDEK INC SALES REPRESENTATIVE TO REPORT THAT THE CUSTOMER REPORTED PITTING LENS. A FOLLOWUP WAS DONE BY NIDEK INC SERVICE MANAGER TO SPEAK WITH THE DOCTOR AND CONFIRMED THAT SHE HAS BEEN HAVING SOME ISSUES WITH PITTING LENS, NO INJURY REPORTED. THE DEVICE EVALUATION WAS COMPLETED AT THE CUSTOMER SITE ON (B)(6) 2022 PER CUSTOMER SERVICE ORDER #(B)(4) BY NIDEK INC FIELD SERVICE ENGINEER. NIDEK INC. CONSIDERS PITTING LENS ISSUE A REPORTABLE EVENT AS IT IS AN UNDESIRABLE CONDITION AND HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE ISSUE WERE TO RECUR. DURING THE VISIT, CUSTOMER INFORMED FSE FOLLOWING: ON (B)(6) 2022, LENS PITTED 4 TIMES WITH 24 SHOTS EMITTED WITH A SETTING OF 1.3MJ POWER OUTPUT AND 250 POSTERIOR. ON (B)(6) 2022, LENS PITTED ONCE WITH 48 SHOTS EMITTED WITH A SETTING OF 1.0MJ POWER OUTPUT AND 275 POSTERIOR. MODE: SINGLE. MAGNIFICATION: 20X. TOTAL SHOT COUNT: 7544. DATE OF MANUFACTURE OF YC-200 S PLUS S/N. (B)(4): (B)(6) 2021. 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. YC-200 DEVICE IS EQUIPPED WITH YAG MODE FUNCTION ONLY. YC-200 S PLUS DEVICE IS EQUIPPED WITH YAG AND SLT MODE FUNCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1521398 YC-200 S PLUS YAG LASER HQF NIDEK CO. LTD. YC-200 04987669101452

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other