BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EC-5000

    MDR report key: 8291217 · Received January 30, 2019

    Report

    Report Number
    0002936921-2019-00001
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Date of Event
    January 3, 2019
    Report Date
    March 13, 2019
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    LZS
    PMA / PMN Number
    P970053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, NIDEK INC. RECEIVED AN EMAIL RESPONSE FROM THE CUSTOMER. THE FACILITY DOCTOR ASSISTING THE CASE MENTIONED THAT THE TARGET TREATMENT WAS FOR PLANO HOWEVER AT THE 6 WEEKS POST-OP FOLLOW-UP HER REFRACTION WAS NOTICED AS +2.00-0.25X36. THE DOCTOR FURTHER ADDED THAT THEY WILL WAIT FOR STABILITY TO BE REGAINED AND PERFORM AN ENHANCEMENT SOMETIME IN APRIL 2019. THERE WERE NO FURTHER CONCERNS WITH THE DEVICE FUNCTIONALITY BY THE USER FACILITY. A ROUTINE PREVENTIVE MAINTENANCE WAS PERFORMED ON THE EXCIMER LASER ON (B)(6) 2019.

    Description of Event or Problem · 0

    PLEASE REFER TO THE INITIAL MDR SUBMITTED ON (B)(6) 2019 FOR DETAILS.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY NIDEK FIELD SERVICE ENGINEER (FSE) ON 01/07/2019 IN THE FIELD, HENCE DEVICE WAS NOT RETURNED TO NIDEK. FSE POWERED ON THE SYSTEM AND FOUND IT IN WORKING ORDER. FSE CALIBRATED LASER WITH REFERENCE TO SECTION 5.3 OF OPERATORS MANUAL. NORMAL 152MJ KV 25.1 FLEX SCAN 148 MJ KV 24.9 HYPEROPIA 48.0 SECONDS. TEST ABLATION WAS PERFORMED AND EVERYTHING WAS PROPER. LASER ALIGNMENT WAS CHECKED AND VERIFIED TO BE PROPER. CHECKED MAX OUTPUT 230MJ. REVIEW OF THE LOGFILES SHOWS MULTIPLE WARNING 17 (NITROGEN ERROR: N2 GAS SECONDARY PRESSURE IS LOW) ON LASER LOG. NITROGEN TANK WAS REPLACED AND LEAK TESTED, ALL PROPER. PREMIX TANK WAS REPLACED AND LEAK TESTED, ALL PROPER. HUMIDITY WAS 22% ON (B)(6) 2019; THE DAY OF THE SURGERY. HUMIDITY RANGE AS PER THE CUSTOMER SITE REQUIREMENTS SHOULD BE 35-45 %. SYSTEM WAS TESTED AND INSPECTED. SYSTEM IS OPERATIONAL. THE OPERATING CONDITIONS RECOMMENDED BY NIDEK ARE: TEMPERATURE SHOULD BE MAINTAINED BETWEEN 15 - 25ºC (59 - 77ºF) AND HUMIDITY BETWEEN 0 - 70% (NON-CONDENSING). HOWEVER, THE FSE NOTICED THAT THE HUMIDITY RANGE DEFINED BY THE CUSTOMER SITE WAS 35-45%. AS PER THE OPERATORS MANUAL IF THE ABOVE ENVIRONMENTAL CONDITIONS ARE NOT SATISFIED, SUFFICIENT LASER POWER OUTPUT MAY NOT BE OBTAINED. THE FSE OBSERVED THAT SEVERAL SURGERIES WERE SCHEDULED AT THE CUSTOMER SITE ON THE DAY OF HIS VISIT (01/07/2019) AND THE DEVICE WAS OPERATIONAL AS EXPECTED. THE CUSTOMER ISSUE WAS INCONCLUSIVE. THE DEVICE FUNCTIONED PROPERLY, NO PROBLEM FOUND DURING TESTS AND INSPECTIONS BY THE FSE.

    Description of Event or Problem · 1

    ON JANUARY 7 2019, NIDEK INC. CUSTOMER SERVICE RECEIVED A TELEPHONE CALL FROM THE USER FACILITY TO REPORT THAT OVERCORRECTION OCCURRED AFTER SURGERY ON (B)(6) 2019 WITH EC-5000, SN: (B)(4). ON (B)(6) 2019 IT WAS CONFIRMED BY THE CUSTOMER THAT THE OVERCORRECTION OCCURRED ON A FEMALE PATIENT. MRS. (B)(6) HAD A 24-HOUR POST-OP APPOINTMENT AND HER OVERCORRECTION WAS DISCOVERED ON THE RIGHT EYE. NIDEK INC. REQUESTED ADDITIONAL PATIENT INFORMATION, BUT NO OTHER PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER AT THAT TIME. IF ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED AT A LATER DATE, A FOLLOW-UP 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83538 EC-5000 EXCIMER LASER LZS NIDEK CO., LTD. EC-5000

    Patients

    Seq Age Sex Outcome Treatment
    1