BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 5894970 · Received August 22, 2016

    Report

    Report Number
    3002807715-2016-00033
    Event Type
    Malfunction
    Date Received
    August 22, 2016
    Report Date
    July 26, 2016
    Manufacturer
    NIDEK CO, LTD
    Product Code
    HQF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN NO ALLEGATION THAT A MALFUNCTION OF THE OPHTHALMIC LASER SYSTEM HAD OCCURRED AT THE TIME OF THIS REPORT. ON 8/22/2016, NIDEK INC QUALITY ENGINEER RECEIVED THE INVESTIGATION REPORT VIA ELECTRONIC MAIL FROM (B)(4) MDR TEAM RELATING TO THE MAUDE REPORT, MW5063321 AS INITIALLY REPORTED BY THE FOOD AND DRUG ADMINISTRATION. INITIAL REPORT PRESENTED TO NIDEK INC SUGGESTED THE DEVICE IN QUESTION WAS A YC-1800; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED AS TO WHAT OTHER SYSTEMS THE UNKNOWN SITE HAD AT THE TIME OF THE REPORT. THE INVESTIGATION REPORT HAS CONCLUDED THAT THE RISK ASSOCIATED WITH THE CLAIM OF "POTENTIALLY DANGEROUS DESIGN FLAW" IS STRICTLY DEPENDENT ON THE LIMITED USER OF THE DEVICE AND PROPER CORRECT OPERATION. ADDITIONALLY, FURTHER REVIEW OF THE RISK MANAGEMENT RECORD INDICATED THAT POTENTIAL RISK ACCEPTABILITY CONTROL ASSOCIATED WITH THIS CLAIM IS ACCEPTABLE. NIDEK CO HAS DETERMINED THAT THE UNKNOWN SITE WAS REFERRING TO THE FUNCTIONALITY OF THE GREEN YAG LASER, GYC-1000 OR MULTI LASER, MC-500 WITH COMBINATION DELIVERY (COMBO DELIVERY) BASED ON THE NARRATIVE, AS DESCRIBED IN THE EVENT DESCRIPTION ON THE MAUDE REPORT, MW5063321. THEREFORE, NIDEK CO HAD CONDUCTED ITS EVALUATION ON THE GYC-1000 AND THE MC-500 UNITS. THE GYC-1000 DEVICE AUTOMATICALLY MEMORIZES THE PREVIOUS SETTINGS USED, AND AS INDICATED IN THE DEVICE OPERATORS MANUAL, THIS IS A BUILT-IN DESIGN SPECIFICATION OF THE DEVICE. MAINTAINING THE PREVIOUS SETTING(S) ON A PRIOR PROCEDURE IS DEPENDENT ON THE USER; BUT HIGHLY NOT RECOMMENDED BY NIDEK CO AS THERE COULD BE POTENTIAL RISK OF UNINTENDED TREATMENT AND NOT OBTAINING THE DESIRED TREATMENT AS EXPECTED. TO AVOID POTENTIAL UNINTENDED HARM AND/OR RISK TO THE PATIENT(S), THE OPERATOR'S MANUAL HAS POINTED THE FOLLOWING SAFETY MEASURES: LIMITED USER: THE OPERATOR OF THE DEVICE IS LIMITED TO OPHTHALMOLOGIST WHO HAS KNOWLEDGE OF THE TREATMENT CONDITION WITH OPHTHALMIC CASES, WHERE ONLY SERVICE TECHNICIANS PROPERLY TRAINED BY NIDEK IS ALLOWED TO INSTALL AND COMPOSITE THE PHOTOCOAGULATION SYSTEM. ONLY PHYSICIANS ARE ALLOWED TO PERFORM RADIATION OF TREATMENT BEAM FOR SURGERY, AS DESCRIBED IN PP 2-4 OF THE GYC-1000 AND PP 10 OF THE MC-500 OPERATOR MANUALS. APPROPRIATE OPERATION: THE OPERATOR'S MANUAL PROVIDES WARNING NOTICE REGARDING LASER TREATMENT: AS INDICATED IN GYC-1000 OPERATOR'S MANUAL, PP 2-6: TO AVOID EXCESSIVE REACTION, SET THE LASER TO A LOW OUTPUT POWER INITIALLY, AND THEN INCREASE IT UNTIL THE DESIRED EFFECT CAN BE OBTAINED. ALWAYS SET THE OUTPUT POWER TO THE MINIMUM AFTER THE LASER EMISSION. AS INDICATED IN MC-500 OPERATOR MANUAL, PP 12: SET THE TREATMENT BEAM TO A LOW POWER OUTPUT INITIALLY, AND THEN INCREASE IT UNTIL THE DESIRED EFFECT CAN BE OBTAINED TO AVOID EMISSION OF EXCESSIVELY INTENSE TREATMENT BEAM. ALWAYS RETURN THE LIGHT INTENSITY TO THE MINIMUM LEVEL AFTER EVERY EXAMINATION. NIDEK INC HAS NOT RECEIVED ANY ADDITIONAL INFORMATION RELATING TO THE EXACT SERIAL NUMBER OF THE SUSPECTED DEVICE. AS OF THE DATE OF THIS REPORT, THE DEVICE IN QUESTION HAS NOT BEEN RETURNED AND/OR EVALUATED BY NIDEK INC AS THERE HAVE BEEN NO FURTHER DETAILS RELATING TO THE NAME OF THE USER FACILITY ASSOCIATED WITH THE DEVICE. ADDITIONALLY, THERE WERE NO ALLEGATIONS OF ANY ADVERSE RELATED EVENTS ASSOCIATED WITH ANY PATIENTS AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AND/OR RECEIVED, A FOLLOW-UP SUPPLEMENTAL REPORT WILL BE SUBMITTED. ALTHOUGH THE DEVICE HAD NO REPORTS OF MALFUNCTION AND/OR ADVERSE RELATED EVENTS, NIDEK INC IS SUBMITTING THE MEDWATCH REPORT TO ERR THE SIDE OF CAUTION.

    Description of Event or Problem · 1

    NIDEK INC RECEIVED A MAUDE REPORT, MW5063321 FROM THE FDA ON 7.26.2016, AND AS DESCRIBED, "NIDEK YC-1800 OPHTHALMIC LASER. POTENTIALLY DANGEROUS DESIGN FLAW. THIS IS A COMBINATION OPHTHALMIC LASER WHEN POWERED ON IN THE PHOTOCOAGULATION. (IE. NON-YAG MODE, THE PREVIOUS USERS' SETTINGS ARE RESTORED, INCLUDING PHOTOCOAGULATION POWER AND DURATION. IF THE PREVIOUS TREATMENT REQUIRED HIGH POWER (EG. LASER IRIDOTOMY) THEN THE MACHINE WILL NEXT POWER UP WITH THE SAME HIGH POWER SETTING. IF THIS IS NOT NOTICED BY THE OPERATOR, THEN A DANGEROUSLY HIGH POWER MAY BE INADVERTENTLY APPLIED TO THE NEXT PATIENT. IT WOULD BE PREFERABLE FOR THE DEVICE TO POWER UP WITH ALL SETTINGS AT MINIMAL LEVELS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544574 YC-1800 YAG LASER HQF NIDEK CO, LTD YC-1800

    Patients

    Seq Age Sex Outcome Treatment
    1