BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EC-5000 QUEST

    MDR report key: 4683631 · Received April 6, 2015

    Report

    Report Number
    3002807715-2015-00017
    Event Type
    Malfunction
    Date Received
    April 6, 2015
    Date of Event
    March 6, 2015
    Report Date
    March 10, 2015
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS NOT RETURNED TO NIDEK FOR EVALUATION. THE DEVICE HAS NOT BEEN EVALUATED YET. NIDEK CLINICAL SPECIALIST CONTACTED THE CUSTOMER AND THE FIELD SERVICE SPECIALIST TO GATHER ADDITIONAL INFO REGARDING THE COMPLAINT WITH SUCCESS. NO INFO IS AVAILABLE AT THIS TIME REGARDING THE STATUS OF THE PATIENTS AND IF ANY FAILURE RELATED TO THE DEVICE WHICH MIGHT HAVE CAUSED THE MALFUNCTION. IF ANY SIGNIFICANT INFO BECOMES AVAILABLE AT LATER DATE A F/U REPORT WILL BE SUBMITTED. NIDEK INC CONSIDERS IT 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. CUSTOMER REPORTED THE PROBLEM OCCURRED WITH THREE DIFFERENT PATIENTS HOWEVER ADDITIONAL DETAILS ARE NOT AVAILABLE AT THIS TIME. NIDEK CONSIDER THIS AS THREE SEPARATE EVENTS NIDEK IS SUBMITTING THREE SEPARATE MDRS FOR UNIT. PLEASE REFER ADDITIONAL MDR: 3002807715-2015-00016 AND 3002807715-2015-00018.

    Description of Event or Problem · 1

    NIDEK, INC. RECEIVED A COMPLAINT FROM A CUSTOMER ON (B)(6) 2015 REGARDING EC-5000 QUEST. CUSTOMER REPORTED THAT DURING THE TREATMENT WITH EC-5000 QUEST SN: (B)(4) THAT THREE HIGH MYOPES WERE UNDER CORRECTED WITH OATZ TREATMENTS BY 1.5 -2.5 D ON (B)(6) 2015. ALL WERE ABOVE -6.0 WITH CYL...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225747 EC-5000 QUEST EXCIMER LASER QUEST LZS NIDEK CO., LTD. EC-5000 QUEST

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK