BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 5115153 · Received September 30, 2015

    Report

    Report Number
    3002807715-2015-00036
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Date of Event
    January 1, 2015
    Report Date
    June 23, 2015
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    HQF
    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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS NOT RETURNED TO NIDEK FOR EVALUATION. HOWEVER, A NIDEK FIELD SERVICE ENGINEER (FSE) HAD CONDUCTED AN ON-SITE EVALUATION. THE DEVICE WAS EVALUATED AND TESTED FOR PROPER OPERATION. AIMING BEAM WAS TESTED ACTUAL ENERGY AND DISPLAY ENERGIES WERE MEASURED AND FSE FOUND THAT THE ACTUAL ENERGY WAS SLIGHTLY LOWER THAN THE DISPLAY. HOWEVER THE ACTUAL ENERGY WAS WITHIN THE RANGE AS PER THE DEVICE SPECIFICATIONS. NO FAILURE WAS FOUND. THE DEVICE WAS CALIBRATED AND THE OUTPUT ENERGIES WERE ADJUSTED. NIDEK CUSTOMER SERVICE CONTACTED FACILITY TO GATHER ADDITIONAL INFORMATION REGARDING COMPLAINT AND TALKED TO OFFICE MANAGER WHO INFORMED THAT AT LIST SIX PATIENTS HAD PITTING IN THE LENS BUT NO SERIOUS ADVERSE EVENT REPORTED. THE DOCTOR COULD COMPLETE THE SURGERIES AND M=NO MEDICAL OR SURGICAL TREATMENT WAS REQUIRED TO ANY OF THE PATIENTS. OFFICE MANAGER ALSO REPORTED THAT THERE WERE BOTH MALE AND FEMALES WITHIN THE RANGE FROM 40 -90 YEARS OF AGE. HOWEVER NO ADDITIONAL DATA WAS PROVIDED. NIDEK CONSIDERS 6 EVENTS AND WILL REPORT 6 MDRS FOR THIS FACILITY. 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. PLEASE REFER ADDITIONAL MDR : 1. 3002807715-2015-00036: FEMALE; AGE BETWEEN 40-90 (AVERAGE 65YRS). 2.3002807715-2015-00037: FEMALE; AGE BETWEEN 40-90 (AVERAGE 65 YRS). 3. 3002807715-2015-00038: FEMALE; AGE BETWEEN 40-90 (AVERAGE 65YRS). 4. 3002807715-2015-00039: MALE; AGE BETWEEN 40-90 (AVERAGE 65YRS). 5. 3002807715-2015-00040: MALE; AGE BETWEEN 40-90 (AVERAGE 65YRS). 6. 3002807715-2015-00041: MALE; AGE BETWEEN 40-90 (AVERAGE 65YRS).

    Description of Event or Problem · 1

    NIDEK RECEIVED A COMPLAINT FOR YC-1800 SN:(B)(4) FROM CUSTOMER ON (B)(6) 2015. DOCTOR CALLED TO REPORT THAT THEY HAVE RECEIVED THE RECALL NOTIFICATION LETTER FOR YC-1800 RECALL AND ALSO THEY HAD EXPERIENCED PITTING LENS IN THE PAST SIX MONTHS. NO ADDITIONAL INFORMATION WAS PROVIDED AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644729 YC-1800 ND:YAG LASER HQF NIDEK CO., LTD. YC-1800

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR