BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 7419968 · Received April 10, 2018

    Report

    Report Number
    0002936921-2018-00004
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    March 13, 2018
    Report Date
    April 9, 2018
    Manufacturer
    NIDEK CO. LTD
    Product Code
    LXS
    UDI-DI
    04987669100073
    PMA / PMN Number
    K893987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SERVICE ON THE DEVICE YC-1800 WAS PERFORMED AT THE USER FACILITY BY A NIDEK INC. FIELD SERVICE ENGINEER (FSE) ON 01-MAY-2018. AS A RESULT OF THE INVESTIGATION BY THE FSE, THE REPORTED FAILURE COULD NOT BE CONFIRMED. FSE POWERED ON THE YC-1800 S/N Y1620072 AND NOTICED THE SHOT COUNTER WAS 03X1000. FSE DID NOT EVALUATE THE SYSTEM AND IT WAS RETURNED TO NIDEK INC. FOR EVALUATION. A NEW YC-1800 S/N Y1620091 WAS INSTALLED AT THE USER FACILITY. FSE VERIFIED SHOT COUNTER = 01 X 1000 AND THE FOLLOWING PARAMETERS: - PROPER FOCUS AND ALIGNMENT OF THE YAG LASER BEAM / AIMING BEAM. - OFFSET FOCUS SHIFT IS PROPER 50 -1500 MICRONS, ANTERIOR AND POSTERIOR - ENERGY OUTPUT IS SPEC, 0.2 - 12.0MJ SINGLE, 0.4 - 22.2MJ DOUBLE BURST, 0.6 - 31.0MJ TRIPLE BURST - OPTICAL BREAKDOWN AT 3.3MJ - TESTED AND INSPECTED THE NEW SYSTEM. SYSTEM IS OPERATIONAL. THE YC-1800 S/N (B)(4). WAS EVALUATED BY A NIDEK INC. SERVIDE ENGINEER (SE) ON (B)(6)2018 BUT COULD NOT DUPLICATE THE CUSTOMER'S REPORTED PROBLEM. SE FOUND PLASMA DISCHARGE AT 6.2 MJ. STANDARD PLASMA DISCHARGE SHOULD BE 5MJ OR LESS. SE REPLACED LASER HEAD ASSEMBLY AND PLASMA DISCHARGE AT 3.8MJ IS 100% AFTER REPLACEMENT. SE CALIBRATED PFN (PULSED FORM NETWORK) VOLTAGE = 390VDC AND FOCUS AND ALIGNMENT OF YAG/AIMING BEAM. LASER OUTPUT WAS VERIFIED TO BE 0.2MJ-11.5MJ IN SPEC. THE SYSTEM IS OPERATIONAL AT ALL THE SETTINGS. SHOULD NEW INFORMATION THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    PLEASE REFER TO INITIAL MDR FOR DETAILS.

    Additional Manufacturer Narrative · 1

    THE OPHTHALMOLOGIST OBSERVED PITTING ON THE POSTERIOR SURFACE OF THE LENS WHILE PERFORMING SURGERY. HOWEVER, THE OPHTHALMOLOGIST COMPLETED THE SURGICAL PROCEDURE BY PERFORMING CERTAIN MODIFICATIONS TO ACHIEVE THE INTENDED RESULTS. NIDEK INC. HAS LEARNED THAT DR. (B)(6) HAS DOUBTS THE EFFECTIVENESS/RELIABILITY OF THE DEVICE IN QUESTION AND THEREFORE, NIDEK HAS DECIDED TO REPLACE IT WITH A NEW YC-1800. THE DEVICE IS NOT YET EVALUATED BY NIDEK INC. A FOLLOW-UP REPORT TO THIS MDR WILL BE SUBMITTED UPON THE COMPLETION OF DEVICE EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE CUSTOMER CONTACTED NIDEK INC. FIELD SERVICE MANAGER WHO LATER COMMUNICATED TO NIDEK INC. CUSTOMER SERVICE MANAGER TO REPORT THAT THE DOCTOR OBSERVED PITTING LENS DURING SURGICAL PROCEDURE. A TOTAL OF 3 INCIDENTS WERE REPORTED AND A SEPARATE MDR WILL BE SUBMITTED FOR EACH CASE. TWO PATIENTS HAVE ACRYSOFT SN60WF MONOFOCAL LENS AND ONE HAVE MULTIFOCAL LENS. THERE WAS NO SERIOUS ADVERSE EVENT REPORTED FROM THE USER FACILITY BUT NIDEK INC. CONSIDERS PITTING LENS ISSUE ON YC-1800 A REPORTABLE EVENT AS IT IS AN UNDESIRABLE CONDITION AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE ISSUE WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254699 YC-1800 YAG LASER LXS NIDEK CO. LTD YC-1800 04987669100073

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| S