BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 7470961 · Received April 27, 2018

    Report

    Report Number
    0002936921-2018-00005
    Event Type
    Malfunction
    Date Received
    April 27, 2018
    Date of Event
    March 14, 2018
    Report Date
    May 9, 2018
    Manufacturer
    NIDEK CO., LTD
    Product Code
    LXS
    PMA / PMN Number
    K893987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2018, NIDEK INC. RECEIVED AN EMAIL RESPONSE FROM THE CUSTOMER. THE FACILITY DOCTOR CLAIMED THAT THERE WERE NO ADVERSE EVENTS TO REPORT. NO PITTING LENSES HAD OCCURRED AND THAT THE AIMING BEAM SEEMED OUT ALIGNMENT, NOT FOCUSING. ALSO, THE DOCTOR HAS MENTIONED THAT NO ISSUES TO REPORT REGARDING ANY PATIENTS. NIDEK DETERMINED THAT NO FURTHER ACTION REQUIRED BASED ON DOCTOR'S REMARK. PLEASE SEE CUSTOMER'S EMAIL RESPONSE FOR COMPLETE DETAILS.

    Description of Event or Problem · 0

    PLEASE SEE THE INITIAL MDR SUBMITTED ON APRIL 27, 2018.

    Additional Manufacturer Narrative · 1

    ON 4/18/2018, THE DEVICE IN QUESTION WAS EVALUATED AT THE USER'S FACILITY BY A NIDEK INC. FIELD SERVICE ENGINEER (FSE). FSE TURNED ON LASER, CHECKED THE FOCUS SHIFT OFF-SET WITH MICROMETER AND AT ZERO (0) OFF-SET. OFF-SET WAS 50 MICRONS ANTERIOR (WITHIN ACCEPTABLE RANGE OF 0 TO ± 50 MICRONS). ALSO CHECKED ACTUAL ENERGY, AT A DISPLAYED VALUE OF 4.4MJ ON LASER THE FIELD MAX METER READS 4.2MJ (WITHIN ACCEPTABLE RANGE TO PRESET VALUE ± 15 %). FSE ADJUSTED THE FOCUS SHIFT OFF-SET TO ZERO MICRON AND ADJUSTED DISPLAY TO MATCH FIELD MAX READINGS AND RETESTED THE LASER. AS EXPECTED, THE LASER IS OPERATIONAL AT ALL SETTINGS AFTER THE SERVICE WAS COMPLETED. NIDEK INC. DETERMINED THAT MOST PROBABLE CAUSE OF THE PITTING LENS REPORTED WAS DUE TO THE COMBINATION OF FOCUS SHIFT OFF-SET BEING SET LESS THAN INDICATED AND USER NOT PROPERLY ALIGNING THE X/Y AXIS DURING THE PROCEDURES.

    Description of Event or Problem · 1

    ON (B)(6) 2018, NIDEK INC. RECEIVED A PHONE CALL FROM A CUSTOMER STATING THAT FOR THE PAST THREE (3) WEEKS, THEIR YC-1800 HAS BEEN PITTING LENSES WHILE PERFORMING PROCEDURES ON PATIENTS. THE CUSTOMER CLAIMED BY TURNING THE LASER OFF AND ON, THE PROCEDURES CAN BE EXECUTED WITH NO ISSUES. AT THIS TIME, NIDEK INCORPORATED HAS NO INFORMATION OF HOW MANY PATIENTS WERE INVOLVED. NIDEK MADE SEVERAL EMAILS AND PHONE CALLS ATTEMPTS, HOWEVER NO REPLY OR RESPONSE FROM THE CUSTOMER. A SUPPLEMENTAL FOLLOW-UP REPORT WILL BE SUBMITTED ONCE PATIENT(S) INFORMATION ARE AVAILABLE. THUS, 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 ISSUE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311362 YC-1800 YAG LASER LXS NIDEK CO., LTD

    Patients

    Seq Age Sex Outcome Treatment
    1