BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINAL FIT SOFTWARE

    MDR report key: 6239728 · Received January 10, 2017

    Report

    Report Number
    0002936921-2016-00005
    Event Type
    Malfunction
    Date Received
    January 10, 2017
    Date of Event
    December 9, 2016
    Report Date
    March 15, 2017
    Manufacturer
    NIDEK INCORPORATED
    Product Code
    HQF
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INITIAL EVALUATION OF THE ISSUE, A NIDEK INC FIELD PERSONNEL DETERMINED THAT RANDOM KEYSTROKE LED TO THE ERROR. HOWEVER, FURTHER EVALUATION OF THE DEVICE/INVESTIGATION OF THE ISSUE IS WORK IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE EVALUATION OF THE DEVICE IS FULLY COMPLETED. KEYSTROKES THAT CAUSE THE ERROR ARE AS FOLLOWS: SELECT PATIENT FILE AND MAP VIEW PASS ENTRY SCREEN CONFIRMATION WITH APPROVED REFRACTION. SWITCH TO OATZ. ENTER 0 CYL AND PRESS OK OR APPLY RE-ENTER. THE PATIENT ATTEMPTED CORRECTION THIS TIME USING ONLY THE MOUSE AND SWITCH BETWEEN CYL, SPH AND AXIS FOR DESIRED REFRACTION. LASER SETTINGS WILL REMAIN AT 0. USE ONLY THE MOUSE. PRESS THE SHOT FILE TO ACTIVATE APPLY AND OK BUTTONS AND PRESS OK TO PROCEED WITH NORMAL SHOT FILE CREATION. PLEASE NOTE THAT AS A RESULT OF THE RANDOM KEY STROKES THE PROCESS, RESULTED IN THE PATIENT BEING UNDER CORRECTED FOR CYL AND OVERCORRECTED ON SPH BY APPROX. 0.75D. HOWEVER, ACCORDING TO A FEEDBACK RECEIVED FROM THE DOCTOR, ALTHOUGH THE PATIENT CONDITION WAS NOT 20/20, SHE WAS VERY EXCITED ABOUT THE IMPROVEMENT SHE ALREADY HAD. THE DOCTOR TOLD HER SHE MAY WANT AN ENHANCEMENT TREATMENT FOR CYLINDER IN THE FUTURE. NIDEK INC. CONSIDERS UNDERCORRECTION ISSUE ON EXCIMER LASER A REPORTABLE EVENT AS THE EC-5000 QUEST HAD MALFUNCTIONED AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Additional Manufacturer Narrative · 1

    NIDEK CO ((B)(4)) PERFORMED FURTHER INVESTIGATION ON THE FINAL FIT SOFTWARE AND DURING DEBUG, AN ERROR WAS OBSERVED IN THE SOFTWARE. NIDEK CO ((B)(4)) DETERMINED THAT THE ERROR IN THE SOFTWARE WAS RELATED WITH THE LASER SETTING FOR FINAL FIT REFRACTIVE SURGERY PLANNING. AS A RESULT IT WAS DECIDED THAT NIDEK WILL BE DOING A FIELD CORRECTION / RECALL WITH THE RECOMMENDED CORRECTION VIA A SOFTWARE UPGRADE. A RECALL REPORT (2936921-02/01/2017-001-C) FOR FINAL FIT SOFTWARE VER.1.11 AND VER.1.12, CUSTOM ABLATION TREATMENT PLANNING SOFTWARE FOR NIDEK EC-5000 EXCIMER LASER SYSTEM HAS BEEN SUBMITTED TO THE FDA ON FEB 01 2017 BY NIDEK INCORPORATED. ALSO, THE EC-5000 QUEST WAS TESTED AT CUSTOMER'S FACILITY AND VERIFIED FOR PROPER FUNCTIONALITY, NIDEK INC FIELD SERVICE ENGINEER DID NOT FIND ANY PROBLEM/ISSUE WITH THE DEVICE. THE PATIENT CONDITION WAS UNDER CORRECTED FOR CYL, NOT NEARLY PERFECT 20/20 VISION BUT VERY EXCITED ABOUT THE IMPROVEMENT AND THE PHYSICIAN CONSIDERED ENHANCEMENT IN THE FUTURE. HOWEVER, NO PATIENT ENHANCEMENT TREATMENT INFORMATION AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A NIDEK INC FIELD SALES MANAGER RECEIVED A TELEPHONE CALL FROM A DOCTOR IN (B)(6) TO REPORT THAT HE HAD CREATED A SHOT FILE WITH ZERO CYL FOR LASER SETTING IN OATZ WHEN HIS ATTEMPTED CORRECTION WAS ACTUALLY -2.25 OF CYL. THIS HAPPENED DURING TREATMENT PLANNING WITHIN FINAL FIT AND ONE OF TWO STEPS OF THE PROCEDURE WAS PROGRAMED, STEP TWO WAS SKIPPED. NO INJURY.

    Description of Event or Problem · 1

    SEE INITIAL MDR 0002936921-2016-00005 FOR DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19542 FINAL FIT SOFTWARE NIDEK EXCIMER LASER QUEST HQF NIDEK INCORPORATED 560092

    Patients

    Seq Age Sex Outcome Treatment
    1