BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EC-5000

    MDR report key: 5664085 · Received May 18, 2016

    Report

    Report Number
    3002807715-2016-00019
    Event Type
    Malfunction
    Date Received
    May 18, 2016
    Date of Event
    April 25, 2016
    Report Date
    April 25, 2016
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    HQF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN REGARDS TO THE "DIFFUSE LAMELLAR KERATITIS COMPLAINT" FOR EC-5000 SN: (B)(4), PER CUSTOMER REQUEST NIDEK FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE ON 4/25/2016 AT THE FIELD. FSE INSPECTED AND TESTED THE DEVICE. THE DEVICE HAS BEEN WORKING AS PER SPECIFICATIONS. NO FAILURE WAS FOUND. DURING THE EVALUATION FSE OBSERVED THAT THE AIR CONDITIONER IN THE ROOM WAS COVERED WITH THE FILTERS. HUMIDIFIERS BUCKET WAS FULL WITH THE WATER. AS PER FSE THE ENVIRONMENTAL CONDITIONS WERE NOT PROPERLY MAINTAINED. NIDEK CLINICAL SPECIALIST CONTACTED FACILITY ON 4/29/2016 TO GATHER ADDITIONAL INFORMATION. ON 5/4/2016 CLINICAL FROM CUSTOMER FACILITY REPLIED BACK AND INFORMED THAT, NIDEK DID NOT PLAY ANY PART IN THE CASE SO THEY ARE WITHDRAWING THE COMPLAINT. NO ADDITIONAL INFORMATION RELATED TO PATIENT STATUS WAS PROVIDED BY THE CUSTOMER. DURING FOLLOW UP CUSTOMER ALSO MENTIONED THAT THEY ARE GOING TO GET THE AIR CONDITIONING SYSTEM CHECKED.

    Description of Event or Problem · 1

    NIDEK INC. RECEIVED A COMPLAINT FROM THE CUSTOMER ON (B)(6) 2016. CUSTOMER REPORTED THAT THEY OBSERVED PATIENT DEVELOPING DIFFUSE KERATITIS POST OPERATIVELY AFTER THE SURGERY. CUSTOMER REQUESTED NIDEK INC. TO INSPECT THE LASER EC-5000 SN: (B)(4). NO ADDITIONAL INFORMATION WAS PROVIDED AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319111 EC-5000 EXCIMER LASER HQF NIDEK CO., LTD. EC-5000

    Patients

    Seq Age Sex Outcome Treatment
    1