BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 6836698 · Received August 31, 2017

    Report

    Report Number
    0002936921-2017-00022
    Event Type
    Malfunction
    Date Received
    August 31, 2017
    Date of Event
    August 18, 2017
    Report Date
    November 22, 2017
    Manufacturer
    NIDEK CO.,LTD
    Product Code
    LXS
    UDI-DI
    04987669100073
    PMA / PMN Number
    K893987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SECOND FOLLOW-UP REPORT IS TO PROVIDE THE DEVICE EVALUATION INFORMATION FOR THE INITIAL MDR REPORTEDLY SUBMITTED ON (B)(6) 2017. ALSO, ON (B)(6) 2017, THE CUSTOMER CALLED BACK TO CONFIRMED THAT THE PATIENT INVOLVED DID NOT REQUIRED ANY MEDICAL INTERVENTION AND DOING WELL. ON NOVEMBER 16, 2017, A NIDEK INC. FIELD SERVICE ENGINEER (FSE) EVALUATED THE YAG LASER IN QUESTION AT THE USER'S FACILITY AND COULD NOT DUPLICATE THE CUSTOMER'S REPORTED PROBLEM. FSE TURNED LASER ON AND IT STARTED WITHOUT ANY ERRORS. FOUND THE LASER OFFSET TO BE SET AT 250UM POSTERIOR. ENERGY WAS SET TO 4.4MJ. MAGNIFICATION WAS SET AT 32X. SHOT COUNT IS 1 X 1000 SHOTS. PLACED ENERGY METER IN FRONT OF LASER AND FOUND ENERGY OUTPUT TO BE WITHIN SPEC. 10MJ=10MJ. DR. WAS USING A NEW PEYMAN CAPSULOTOMY LENS. TEST FIRED LASER ON ZAP-IT PAPER AND FOUND YAG BEAM AND AIMING BEAM PAR FOCAL AT 0 OFFSET. FSE TEST FIRED LASER ON ZAP IT PAPER TO TEST OPTICAL CENTER OF YAG BEAM AND AIMING BEAM, BOTH WERE IN PERFECT ALIGNMENT. INSTRUCTED DOCTOR TO USE THE METAL FOCUS ROD TO SET THE FOCUS ON THE EYEPIECES BEFORE THE PROCEDURE. AND ALSO HAD DOCTOR TO USE 2.2MJ FOR THE STARTING ENERGY AND AN OFFSET OF 250UM. TREATED PATIENTS SUCCESSFULLY USING THE YAG LASER FOR THE CAPSULOTOMY PROCEDURE AND REPORTED NO LENS PITTING OCCURRED. LASER WAS TESTED AND READY TO BE USED, THE LASER WAS OPERATIONAL AT ALL THE SETTINGS. IN CONCLUSION, NIDEK INC DETERMINED THAT THE PROBABLE CAUSE OF YAG LASER ENERGY REACTION ISSUE WAS INCONCLUSIVE. TEST AND INSPECTION WERE PERFORMED ON THE DEVICE AND NO PROBLEM OBSERVED. IN GOOD MEASURE, NIDEK INC. FIELD SERVICE ENGINEER PERFORMED IN-SERVICE TRAINING WITH THE DOCTOR TO ALLOW LASER TO BE USED AS DESIGNED, AND THE DOCTOR HAS CONFIRMED THAT CAPSULOTOMY PROCEDURES WERE SUCCESSFUL.

    Additional Manufacturer Narrative · 1

    AT THIS TIME THERE IS NO SERVICE EVALUATION ON THE DEVICE IN QUESTION. THIS SO BECAUSE, SEVERAL ATTEMPTS TO REACH THE CUSTOMER BY OUR CUSTOMER SERVICE MANAGER HAVE BEEN UNSUCCESSFUL; THE CUSTOMER SERVICE DEPARTMENTS MADE PHONE CALLS ON (B)(6) 2017, (B)(6) 2017 AND (B)(6) 2017 AS WELL AS LEFT MESSAGES. HOWEVER, THERE WAS NO RESPONSE FROM CUSTOMER. ON (B)(6) 2017, CUSTOMER FINALLY CALLED BACK AND HAS AGREED TO SCHEDULE THE DEVICE EVALUATION/SERVICE TO BE PERFORMED ON (B)(6) 2017. A SECOND FOLLOW-UP WILL BE SUBMITTED ONCE THE EVALUATION COMPLETION OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    NIDEK INC. CONSIDERS PITTING LENS ISSUE ON YAG LASER A REPORTABLE EVENT AS THE YC-1800 HAD MALFUNCTIONED AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. DEVICE EVALUATION IN WORK PROCESS, A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE DEVICE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    SEE INITIAL MDR 0002936921-2017-00022 FOR DETAILS.

    Description of Event or Problem · 1

    SEE INITIAL MDR 0002936921-2017-00022 SUBMITTED ON (B)(6) 2017.

    Description of Event or Problem · 1

    ON (B)(6) 2017, NIDEK INC. CUSTOMER SERVICE RECEIVED A TELEPHONE CALL FROM A CUSTOMER TO REPORT THAT THEIR YC-1800 YAG LASER WAS NOT GETTING THE SAME REACTION AND CAUSED MILD PITTING DURING SURGICAL PROCEDURE. BASED ON DOCTOR'S REMARKS, WHEN THE ENERGY POWER WAS SET AT 2 MJ, NOTHING HAPPENS TO THE LENS/CAPSULE DURING START OF POSTERIOR. WHEN FIRING, LOOKS LIKE NICKS IN THE IOL. HIGHER ENERGY NEAR THE CENTER OF THE IOL WAS NOT USED, BECAUSE OF SOME MILD PITTING. THE PROCEDURE WAS EVENTUALLY COMPLETED BY TURNING THE ENERGY UP TO AROUND 2.4-2.6 MJ AND AIMING POSTERIORLY. NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614556 YC-1800 YAG LASER LXS NIDEK CO.,LTD YC-1800 04987669100073

    Patients

    Seq Age Sex Outcome Treatment
    1