BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 4905206 · Received July 7, 2015

    Report

    Report Number
    3002807715-2015-00029
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Date of Event
    January 1, 2015
    Report Date
    October 22, 2015
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    LXS
    PMA / PMN Number
    K893987
    Removal / Correction Number
    2936921-2/20/2015-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE HAS NOT BEEN RETURNED TO NIDEK. THE INSPECTION HAS NOT DONE YET SO THE RESULTS OF EVALUATION ARE NOT AVAILABLE. NIDEK CUSTOMER SERVICE MANAGER CONTACTED CUSTOMER TO GATHER ADDITIONAL INFORMATION. DOCTOR CONFIRMED THAT IN TOTAL FIVE PATIENTS HAD PITTING IN THE LENS OVER THE PERIOD OF 6 MONTHS. DATES OF SURGERY HAVE NOT BEEN PROVIDED. HOWEVER DOCTOR PROVIDED PATIENT INFORMATION AND CONFIRMED THAT NONE OF THE PATIENTS HAND ANY KIND OF ADVERSE EVENTS AND NO MEDICAL AND SURGICAL TREATMENT WAS REQUIRED FOR PITTING. NIDEK ASKED CUSTOMER TO SEND THE DEVICE BACK TO NIDEK FOR EVALUATION. THE DEVICE WILL BE EVALUATED BY THE NIDEK SERVICE ENGINEER. SHOULD NEW INFORMATION THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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. ADDITIONAL FOUR MDRS WILL BE SUBMITTED FOR ADDITIONAL FOUR PATIENTS.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED BACK TO NIDEK ON 9/23/2015. THE DEVICE WAS EVALUATED BY NIDEK SERVICE ENGINEER (SE) ON 10/22/2015. THE DEVICE WAS TESTED AND INSPECTED FOR PROPER FUNCTION. THE LASER ENERGY OUTPUT WAS TESTED AND VERIFIED. FOCUS AND ALIGNMENT OF YAG/ AIMING BEAM WAS CHECK AND VERIFIED. NO FAILURE WAS FOUND. THE SE CONFIRMED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. HOWEVER, AS PER CUSTOMER'S REQUEST THE DEVICE WAS EXCHANGED WITH ANOTHER YC-1800 SN: (B)(4) BY NIDEK.

    Description of Event or Problem · 1

    NIDEK INC. RECEIVED A COMPLAINT FROM A CUSTOMER ON (B)(6) 2015. DOCTOR REPORTED THAT HE HAD RECEIVED THE NIDEK INC. YC-1800 RECALL NOTIFICATION LETTER. DOCTOR ALSO REPORTED THAT HE HAD NOTICED PITTING LENS IN 5 OF HIS PATIENTS. DOCTOR MENTIONED THAT IT WAS JUST SMALL PITTING AND NONE OF THE PATIENTS HAD ANY ADVERSE EVENTS AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440096 YC-1800 ND: YAG LASER LXS NIDEK CO., LTD. YC-1800

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR