BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 5115119 · Received September 30, 2015

    Report

    Report Number
    3002807715-2015-00045
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Report Date
    July 1, 2015
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    HQF
    PMA / PMN Number
    K893987
    Removal / Correction Number
    2936921-2/20/2015-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE HAS NOT BEEN RETURNED TO NIDEK. HOWEVER, A NIDEK FIELD SERVICE ENGINEER (FSE) HAD CONDUCTED AN ON-SITE EVALUATION. THE DEVICE WAS TESTED AND EVALUATED FOR PROPER OPERATION. THE TREATMENT OUTPUT ENERGIES WERE CHECKED AND WERE WITHIN SPECIFICATIONS ON EVALUATION FSE OBSERVED SEVERAL SPOTS AND DUST ON OCULARS AND OBJECTIVE LENS. FSE CLEANED THE OCULARS AND THE OBJECTIVE LENS. THE DEVICE HAS BEEN FUNCTIONING PROPERLY. NIDEK CLINICAL SPECIALIST CONTACTED CUSTOMER TO GATHER ADDITIONAL INFORMATION REGARDING COMPLAINT. CUSTOMER REPORTED THAT THEY HAD ISSUE OF PITTING LENS IN THE PAST. CUSTOMER DID NOT PROVIDE ANY INFORMATION REGARDING THE NUMBER OF PATIENTS AFFECTED AS THE CUSTOMER SAID DOCTOR OBSERVED ONLY MINOR PITTING IN FEW CASES BUT NOT VERY SIGNIFICANT AND NONE OF THE PATIENTS HAD ANY SERIOUS OUTCOME. CUSTOMER ALSO REPORTED THAT DOCTOR HAD SOME ISSUES WITH FOCUSING BUT AFTER THE SERVICE BOTH THE ISSUES WERE RESOLVED AND NOW DOCTOR DOES NOT OBSERVE ANY PITTING AND THE FOCUSING IS ALSO BETTER. NIDEK WOULD BE SUBMITTING SINGLE MDR AT THIS TIME AS THE NUMBER OF PATIENTS AFFECTED WAS NOT CONFIRMED. SHOULD NEW INFORMATION THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NIDEK WOULD LIKE TO CONFIRM THAT THE FOCUSING ISSUE COULD HAVE BEEN DUE TO DIRTY OPTICS. 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 RECEIVED A COMPLAINT FROM CUSTOMER ON (B)(4) 2015. NIDEK RECALL TEAM CONTACTED CUSTOMER REGARDING YC-1800 RECALL; DURING THAT TIME, TECHNICIAN REPORTED THAT DOCTOR HAD EXPERIENCED PITTING LENS IN THE PAST. NO ADDITIONAL DETAILS WERE PROVIDED AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645112 YC-1800 ND: YAG LASER HQF NIDEK CO., LTD. YC-1800

    Patients

    Seq Age Sex Outcome Treatment
    1