BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-200 S PLUS

    MDR report key: 13231239 · Received January 11, 2022

    Report

    Report Number
    0002936921-2022-00001
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    December 15, 2021
    Report Date
    January 20, 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. CONSIDERS PITTING LENS ISSUE ON YAG LASER A REPORTABLE EVENT AS THE YC-200 HAD MALFUNCTION AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. NIDEK INC. FIELD SERVICE MANAGER (FSM) WENT ON THE CUSTOMER SITE TO INSPECT AND PERFORM SERVICE ACTIVITIES ON 12/21/2021. NO ISSUE OBSERVED ON YC-200 S PLUS YAG LASER (B)(4). THE ROOT CAUSE OF THE REPORTED ISSUE "PITTING ON IOL" IS INCONCLUSIVE. AS A PREVENTIVE MEASURE, FOOT SWITCH (PART NO. 17330-0012) WAS INSTALLED AS AN OPTION TO HELP PREVENT PITTING OF THE IOL DURING SURGERY. IF THE FOOTSWITCH IS USED, NO FLINCHING / MOVEMENT OF THE JOYSTICK WHILE THE TRIGGER BUTTON IS PRESSED.

    Additional Manufacturer Narrative · 0

    NIDEK INC. RECEIVED ADDITIONAL INFORMATION ABOUT DATE OF OCCURRENCE FROM THE CUSTOMER ON 01/19/2022. THE CUSTOMER STATED THAT THE PITTING LENS ISSUE OCCURRED ON (B)(6) 2021. THERE WERE THREE INCIDENT AT THE CUSTOMER SITE WITH SAME DEVICE YC-200 S PLUS S/N. (B)(6). NIDEK INC. CONSIDERS PITTING LENS ISSUE A REPORTABLE EVENT AS IT IS AN UNDESIRABLE CONDITION AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE ISSUES WERE TO RECUR. AS REPORTED IN THE INITIAL MDR REPORT, NIDEK INC FIELD SERVICE MANAGER WENT ON THE CUSTOMER SITE TO INSPECT AND PERFORM SERVICE ACTIVITIES ON 12/21/2021. NO ISSUE OBSERVED ON THE DEVICE.

    Description of Event or Problem · 0

    ON DECEMBER 17, 2021. NIDEK INC CUSTOMER SERVICE REPRESENTATIVE RECEIVED AN EMAIL FROM THE CUSTOMER TO REPORT THAT THE DOCTORS NOTICED SOME PITTING ON THE IOL DURING CAPSULOTOMY PROCEDURES. THE ISSUE OCCURRED WHILE USING YC-200 S PLUS YAG LASER (B)(4) IN THE FACILITY'S LASER ROOM. FOLLOW UPS WERE MADE TO THE CUSTOMER BY RA/QA DIRECTOR AND FIELD SERVICE MANAGER BETWEEN THE DATES OF 12/17-12/23/2021; NO RESPONSE RECEIVED TO CONFIRM THE DATE OF OCCURRENCE. NO INJURY TO PATIENTS WAS REPORTED. LASER WAS INSPECTED/SERVICED IN THE FIELD AT THE CUSTOMER'S OFFICE PER NIDEK REFERENCE# (B)(4).

    Description of Event or Problem · 0

    PLEASE SEE INITIAL MDR SUBMITTED ON 01/11/2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887988 YC-200 S PLUS YAG LASER HQF NIDEK CO. LTD. YC-200 04987669101452

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| H