BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 5807514 · Received July 19, 2016

    Report

    Report Number
    3002807715-2016-00027
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    June 20, 2016
    Report Date
    September 21, 2016
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    HQF
    PMA / PMN Number
    K893987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EVALUATED .THE DEVICE WILL BE RETURNED BACK TO NIDEK (B)(4) FOR FURTHER EVALUATION. CUSTOMER HAS BEEN PROVIDED WITH THE LONER DEVICE. NIDEK CUSTOMER SERVICE REPRESENTATIVE CONTACTED CUSTOMER TO GATHER ADDITIONAL INFORMATION REGARDING ANY INJURY OR ADVERSE EVENT ASSOCIATED TO THE EVENT AND CONFIRMED THAT NO INJURY OCCURRED DURING THE FLASHBACK EVENT. CUSTOMER REPORTED TWO SEPARATE INCIDENTS. NIDEK INC. IS SUBMITTING TWO SEPARATE MDRS FOR TWO SEPARATE EVENTS. PLEASE REFER THE LIST OF MDR SUBMITTED FOR THIS COMPLAINT. MDR #: 3002807715-2016-00027, MODEL: YC-1800, COMPLAINT: FLASHBACK, SERIAL NUMBER: (B)(4), DATE OF AWARENESS: 1ST INCIDENT: (B)(6) 2016. 3002807715-2016-00028, YC-1800, FLASHBACK, 80049, 2ND INCIDENT: (B)(6) 2016. NO PATIENT INJURY WAS REPORTED SO NO PATIENT INFORMATION IS AVAILABLE. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE YC-1800 YAG LASER SERIAL #(B)(4) WAS RETURNED TO NIDEK CO. ((B)(4)) FOR FURTHER EVALUATION. NIDEK CO. INVESTIGATION SUMMARY: INSPECTION AND TEST WERE PERFORMED TO VERIFY AND/OR DUPLICATE THE POSSIBLE CAUSES FOR FLASHBACK ISSUE. DURING INSPECTION, THE PROTECTIVE FILTER WAS SECURELY MOUNTED TO THE SLIP LAMP. THE TRANSMITTANCE OF THE PROTECTIVE FILTER WAS MEASURED AND THE RESULT OF TRANSMITTANCE MEASUREMENT OF THE PROTECTIVE FILTER (SPECIFICATION OF TRANSMITTANCE: LESS THAN 0.05%) AT 1,064NM WAS 0.04%. IT WAS CONFIRMED THAT THE RESULT MET THE SPECIFICATION. POWER METER WAS PLACED AT THE OPERATOR'S SIDE OF THE PROTECTIVE FILTER. THE WHITE PAPER SIMULATING THE REFLECTION OF LASER BEAM IN A POSITION SHIFTED ABOUT 1CM FROM YAG LASER FOCAL POINT TOWARD OPERATOR'S SIDE. THE MEASURED POWER OF POWER OF OPERATOR'S SIDE WAS 0.0MJ (LASER SET VALUE: 0.2MJ AND 10.2MJ/POWER METER WAVELENGTH: 1,064NM). THE LASER BEAM WAS EMITTED TO TEST PAPER BURN AT SET VALUE 5.0MJ AND THE LASER BURN PATTERN RESULTED WITH NO PROBLEM. OPERATED THE SYSTEM WITH STANDARD USE AND ELEVATED ANY FLASHBACK THROUGH BINOCULAR OPHTHALMOSCOPE SET TO 5MJ. FLASHBACK WAS NOT DUPLICATED THROUGH BINOCULAR OPHTHALMOSCOPE. NIDEK CO. HAD DETERMINED THAT THE PROBABLE/ROOT CAUSE OF THE FLASHBACK ISSUE WAS INCONCLUSIVE. ADDITIONAL INFORMATION CAN BE VERIFIED UNDER THE FOLLOWING IN THIS FORM REPORT DATE, DESCRIBE EVENT OR PROBLEM, DEVICE AVAILABLE FOR EVALUATION?, REPORT SOURCE, DATE RECEIVED BY MFR, TYPE OF REPORTS, IF FOLLOW-UP, WHAT TYPE?, DEVICE EVALUATED BY MFR?, EVALUATION CODES AND ADDITIONAL MFR NARRATIVE.

    Description of Event or Problem · 1

    NIDEK INC. RECEIVED A COMPLAINT FROM THE CUSTOMER ON 6/21/2016. CUSTOMER REPORTED THAT THE SYSTEM YC-1800 SN: (B)(4), WAS REPAIRED ON (B)(6) 2016. AFTER THE REPAIR TWO DOCTORS REPORTED THAT THEY EXPERIENCED A FLASH BACK WHILE PERFORMING LASER TREATMENTS ON PATIENTS. NO INJURY WAS REPORTED THAT TIME. TWO INCIDENTS REPORTED. 1ST INCIDENT OCCURRED (B)(6) 2016 (AFTER SYSTEM WAS REPAIRED) THEN THE 2ND INCIDENT OCCURRED (B)(6) 2016.

    Description of Event or Problem · 1

    SEE INITIAL MDR 3002807715-2016-00027 FOR DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460297 YC-1800 ND:YAG LASER HQF NIDEK CO., LTD. YC-1800

    Patients

    Seq Age Sex Outcome Treatment
    1