BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 9351336 · Received November 20, 2019

    Report

    Report Number
    0002936921-2019-00010
    Event Type
    Malfunction
    Date Received
    November 20, 2019
    Date of Event
    November 13, 2019
    Report Date
    January 29, 2020
    Manufacturer
    NIDEK CO. LTD.
    Product Code
    LXS
    UDI-DI
    04987669100073
    PMA / PMN Number
    K893987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE YAG LASER, YC-1800 DEVICE S/N.(B)(4) WAS EVALUATED BY NIDEK INC. IN-HOUSE TECHNICAL ENGINEER PER CSO-19-0681. NIDEK INC IN-HOUSE TECHNICAL ENGINEER PERFORMED THE FOLLOWING SERVICE ACTIVITIES TO INVESTIGATE THE REPORTED ISSUE: · ENGINEER CONFIRMED THAT THE PROTECTIVE FILTER WAS SECURELY MOUNTED TO SLIT LAMP. · POWER METER WAS PLACED AT THE OPERATOR'S SIDE OF THE PROTECTIVE FILTER. ENGINEER PUT THE WHITE PAPER SIMULATING THE REFLECTION OF LASER BEAM IN A POSITION SHIFTED ABOUT 1CM FROM YAG LASER FOCAL POINT TOWARD OPERATOR'S SIDE. THE MEASURED POWER OF OPERATOR'S SIDE WAS 0.0MJ (LASER SET VALUE: 0.2MJ AND 10.2MJ/POWER METER WAVELENGTH: 1,064NM). · ENGINEER VERIFIED THAT THE LASER BEAM WAS EMITTED TO THE TEST PAPER (BURN PAPER) AT THE SET VALUE 5.0MJ. THE LASER BURN PATTERN ON THE TEST PAPER HAD NO ISSUES. · ENGINEER OPERATED THE SYSTEM WITH STANDARD USE AND EVALUATED ANY FLASHBACK THROUGH BINOCULAR OPHTHALMOSCOPE AT THE SET VALUE 5.0MJ. FLASHBACK WAS NOT DUPLICATED THROUGH BINOCULAR OPHTHALMOSCOPE. · EVALUATION OF COMPONENT PARTS: + NO CLEARANCE BETWEEN HOLDER (163765-M462) AND FILTER (13704-GA05) OBSERVED. + NO DAMAGE ON THE FILTER AND THE HOLDER OBSERVED. + NO ISSUE WAS FOUND WITH THE ADHESIVE, AND THE FILTER WAS SECURELY FIXED IN THE HOLDER (163765-M462). NIDEK INC COULD NOT DUPLICATE THE REPORTED COMPLAINT "RETINAL SCOTOMA" FROM FLASHBACK. THE CAUSE OF THE ISSUE IS INCONCLUSIVE.

    Description of Event or Problem · 0

    PLEASE SEE INITIAL MDR SUBMISSION ON (B)(6) 2019.

    Additional Manufacturer Narrative · 1

    INITIAL EVALUATION OF THE YAG LASER (SERIAL#: (B)(4)) WAS COMPLETED ON 11/18/2019 IN THE FIELD WITH NO ISSUES FOUND. THE FOLLOWING FIELD SERVICE ACTIVITIES WERE COMPLETED ON 11/18/2019: COMPLAINT VERIFIED/ISSUE DUPLICATED: NO. TESTING PERFORMED AND OBSERVATION: POWERED ON THE YC - 1800. SHOT COUNTER = 6 X 1000. NO ERROR CODES IN MEMORY. VERSION 1.01 OBSERVED SETTINGS : ENERGY = 0.2MJ; 0 MICRON OFFSET; OCULARS AT 0,0; MAGNIFICATION 20X; AIMING BEAM AT INTENSITY LEVEL 6 AND ROTATED 45 DEGREES; ILLUMINATION INTENSITY AT MAXIMUM, 4MM SLIT WIDTH. THE AIMING BEAM AND YAG LASER BEAM ARE COINCIDENT AND IN FOCUS. SERVICE PERFORMED: MEASURED AIMING BEAM INTENSITY: MIN = 0.62MICRO-JOULES, LEVEL 6 = 3.88MICRO-JOULES, MAX = 28.3MICRO-JOULES - ALL NORMAL LEVELS. MEASURED ENERGY OUTPUT AND FOUND IN PROPER SPECIFICATION : 0.3MJ AT 0.3MJ, 1.17MJ AT 1.1MJ, 3.52MJ AT 3.4MJ, 5.6MJ AT 5.4MJ, 12.2MJ AT 11.4MJ, 22.69MJ AT 10.6MJ X2, 32.0MJ AT 10.0MJX3 INSPECTED OCULARS AND FIXED YAG FILTER, NO PROBLEMS FOUND. CHECKED PULSE FORMING NETWORK VOLTAGE = 380VDC - PROPER. REMOVED COVERS AND INSPECTED INTERNAL COMPONENTS AND OPTICAL PATH. CHECKED THE ILLUMINATION BULB AND SLIT MECHANISM - PROPER. INSPECTED THE ABRAHAM YAG IRIDOTOMY CONTACT LENS - APPEARS GOOD. CLEANED INTERNAL AND EXTERNAL OPTICS AND OCULARS. THE SYSTEM WAS TESTED AND INSPECTED AT ALL SETTINGS. THE SYSTEM IS OPERATIONAL. CONCLUSION: COULD NOT DUPLICATE THE STATED COMPLAINT, IT IS INCONCLUSIVE. DEVICE TO BE RETURNED IN-HOUSE FOR FULL EVALUATION. A SUPPLEMENTAL FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE DEVICE EVALUATION AND REPAIR ARE COMPLETED.

    Description of Event or Problem · 1

    ON (B)(6) 2019, A DOCTOR FROM (B)(6) HAS REPORTED THAT AFTER COMPLETING A YAG IRIDOTOMY ON A PATIENT ON (B)(6) 2019, IMMEDIATELY AFTER TAKING HER EYES OFF THE OCULARS, SHE EXPERIENCED A BRIGHT RED HORIZONTAL RECTANGULAR SCOTOMA ON EACH EYE, A FEW DEGREES OFF-CENTER. AFTER 3 MINUTES, THE SCOTOMA DISAPPEARED BUT THE DOCTOR WAS STILL EXPERIENCING A BURNING SENSATION IN THE LEFT EYE AND REDNESS IN BOTH EYES (BUT MORE ON THE LEFT EYE THAN THE RIGHT). THE DEVICE S/N (B)(4) WAS INSTALLED IN (B)(6) 2018 AND HAS NOT BEEN SERVICED SINCE THE INITIAL INSTALLATION. THIS WAS THEIR FIRST CALL TO NIDEK WITH AN ISSUE. NIDEK INC. SENIOR PRODUCT MARKETING MANAGER SPOKE TO DR. (B)(6) ON 11/14/2019. ACCORDING TO THE DOCTOR, THE SYMPTOMS RESOLVED NATURALLY AND HER VISION IS FINE NOW WITHOUT THE SCOTOMAS OR REDNESS IN THE EYES. NIDEK INC. FIELD SERVICE VISITED THE SITE ON 11/18/2019 AND DURING THIS INITIAL INSPECTION, NO ISSUES WITH THE DEVICE WERE FOUND (COULD NOT DUPLICATE THE STATED COMPLAINT). THE DEVICE IS BEING RETURNED IN-HOUSE FOR A MORE DETAILED EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140747 YC-1800 YAG LASER LXS NIDEK CO. LTD. YC-1800 04987669100073

    Patients

    Seq Age Sex Outcome Treatment
    1