BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 4759873 · Received May 5, 2015

    Report

    Report Number
    3002807715-2015-00019
    Event Type
    Malfunction
    Date Received
    May 5, 2015
    Date of Event
    January 1, 2015
    Report Date
    June 29, 2015
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    LXS
    PMA / PMN Number
    K893987
    Removal / Correction Number
    2936921-2/20/2015-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE YC-1800; SN (B)(4) WAS RETURNED TO THE NIDEK ON (B)(6) 2015. THE DEVICE WAS TESTED AND EVALUATED BY THE NIDEK SERVICE ENGINEER (SE). THE TREATMENT OUTPUT ENERGIES WERE TESTED AND VERIFIED AND WERE WITHIN THE SPECIFICATIONS. FOCUS AND ALIGNMENT OF THE YAG AND AIMING BEAM WERE CHECKED AND WERE WITHIN SPECIFICATIONS. FOCUS SHIFT WAS CHECKED AND WAS OKAY. OPTICAL BREAKDOWN WAS WITHIN SPECIFICATIONS. THE DEVICE WAS WITHIN SPECIFICATIONS AND NO FAILURE WAS FOUND. THE DEVICE WAS CALIBRATED AND TESTED FOR PROPER OPERATION.

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE HAS NOT BEEN RETURNED TO NIDEK. THE EVALUATION HAS NOT DONE YET SO THE RESULTS OF EVALUATION ARE NOT AVAILABLE. NIDEK CONTACTED THE FACILITY AND TALKED TO THE DOCTOR REGARDING THE LETTER HE SENT IN WITH THE RECALL NOTICE. DOCTOR REPORTED THAT THERE IS NO PATIENT INJURY AND NO SURGICAL TREATMENTS NEEDED TO REPAIR ANY INJURY. NIDEK CONFIRMED THAT THERE IS NO CONFIRMED INCIDENCE OF PITTING LENS AT THIS TIME. DOCTOR MENTIONED THAT THE REASON TO REPORT A COMPLAINT WAS THAT HE WAS DISSATISFIED AS A PHYSICIAN AS HIS LASER WAS NOT TREATING AS IT SHOULD. NIDEK WILL SUBMIT THE FOLLOW UP REPORT IF ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED AT A LATER DATE AFTER THE EVALUATION. NIDEK CONSIDERS THIS FAILURE MODE A REPORTABLE EVENT AS THE DEVICE HAS MALFUNCTIONED AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    NIDEK INC RECEIVED A COMPLAINT FROM A CUSTOMER ON (B)(6) 2015 REGARDING YC-1800 SN (B)(4). CUSTOMER SENT IN A LETTER WITH YC-1800 RECALL NOTIFICATION. CUSTOMER COMPLAINT ABOUT TWO RECURRING PROBLEMS ASSOCIATED WITH THE YC-1800. THE FIRST IS THAT THE LASER FIRES BLANKS AND THE SECOND IS LENS PITTING. DOCTOR EXPLAINED ABOUT THE FIRING BLANKS AS WHEN HE PRESSED THE TRIGGER TO FIRE THE LASER HE HEARD A TYPICAL CLICKING SOUND BUT DID NOT SEE ANY ENERGY DELIVERED AND NO CHANGE TO THE CAPSULE, LENS OR NO GAS BUBBLE FORMATION. ACCORDING TO THE CUSTOMER HE INFORMED THIS ISSUE TO ONE OF THE NIDEK REPRESENTATIVES AT ONE OF THE (B)(6) MEETINGS. THE LASER WAS EXCHANGED SOON AFTER THAT. THE PROBLEM WAS BETTER FOR A WHILE, BUT THEY HAD THE SAME PROBLEM WITH THE SECOND LASER. NIDEK REPRESENTATIVE SUGGESTED THE DOCTOR TO INCREASE THE ENERGY OF THE LASER TO AVOID THE PROBLEM OF FIRING BLANKS. THIS SEEMED TO HELP THAT PROBLEM, BUT INCREASED THE RISK OF LENS PITTING. DOCTOR ALSO INFORMED THAT HE HAS RECEIVED A NOTIFICATION LETTER REGARDING THE YC-1800 RECALL AND HAS REREAD THE OPERATOR'S MANUAL AND FOLLOWED THE PROCEDURES. THIS DID SEEM TO HELP SLIGHTLY WITH THE PROBLEM OF LENS PITTING, BUT HAS NOT RESOLVED IT AND THE PROBLEM OF FIRING BLANKS IS STILL THERE. NO INJURY WAS REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295606 YC-1800 ND YAG LASER LXS NIDEK CO., LTD. YC-1800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK