BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYC-500D

    MDR report key: 7558683 · Received May 31, 2018

    Report

    Report Number
    0002936921-2018-00007
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Date of Event
    May 14, 2018
    Report Date
    May 31, 2018
    Manufacturer
    NIDEK INC.
    Product Code
    HQF
    UDI-DI
    04987669100851
    PMA / PMN Number
    K152603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NIDEK FIELD SERVICE ENGINEER (FSE) WENT TO THE FIELD FOR DEVICE EVALUATION ON (B)(6) 2018. THE DEVICE WAS TESTED AND EVALUATED BY THE FSE. CUSTOMER COMPLAINT FOR INTENSE FLASHBACK DURING LASER FIRING ON THE DEVICE GYC-500D SERIAL NUMBER: (B)(4) COULD NOT BE DUPLICATED. FSE POWERED ON THE SYSTEM AND FOUND IN WORKING ORDER. TESTED ENERGIES AT 100 MW, 200 MW AND 500 MW AND ALL ARE PROPER. FSE REMOVED THE OCULARS AND TESTED 532 NM FILTER FOR ANY FLASHBACK BUT COULD STILL NOT DUPLICATE ANY FLASH BACK. CHECKED 532 NM FILTER FOR ANY CRACKS OR SCRATCHES AND FOUND EVERYTHING WAS PROPER. TESTED FUNCTION OF FILTER ALL PROPER. RESEATED MICROSCOPE OCULARS AND TEST FIRE ON ORANGE PAPER FOR PROPER ALIGNMENT AND SPOT SIZE. NO PROBLEM FOUND DURING DEVICE EVALUATION AS THE FLASHBACK AND LOW ENERGIES WERE INCONCLUSIVE. THEREBY, NIDEK INC. DETERMINED THAT THE CUSTOMER'S COMPLAINT ISSUE WAS INCONCLUSIVE. THE USE OF UNIVERSAL MIRROR LENS ( VOLK HR WIDE FIELD) COULD HAVE CAUSED FLASH/REFLECTION THAT COULD HAVE BEEN INTERPRETED AS FLASHBACK BY THE DOCTOR. IF ADDITIONAL SIGNIFICANT INFORMATION IS AVAILABLE AT A LATER DATE, A FOLLOW-UP REPORT WILL BE SUBMITTED. NIDEK INC. CONSIDERS FLASHBACK ISSUE 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.

    Description of Event or Problem · 1

    NIDEK INC. RECEIVED A COMPLAINT FROM OUR TERRITORY SALES MANAGER ON (B)(6) 2018 THAT THE CUSTOMER (RETINA SPECIALIST) WAS EXPERIENCING INTENSE FLASHBACK DURING LASER FIRING. THE DOCTOR WAS PERFORMING PRP (PANRETINAL PHOTOCOAGULATION) ON A PATIENT USING GYC-500D VIA SL 1800 AND A NEW LASER LENS. THE DOCTOR REPORTED OF BEING UNABLE TO EFFECTIVELY TREAT THE PATIENT IN SPITE OF A CLEAR VIEW/FOCUS USING 200NM SPOT SIZE / POWER 1200MW AT .10 SEC EXPOSURE EVERY .20 SECONDS HOLDING PEDAL DOWN. THE EPISODE OF FLASHING LASTED THROUGHT THE DURATION OF THE LASER PULSE. NO INJURY WAS REPORTED THAT TIME AND HENCE NO PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398301 GYC-500D GREEN LASER PHOTOCOAGULATOR SYSTEM HQF NIDEK INC. GYC-500D 04987669100851

    Patients

    Seq Age Sex Outcome Treatment
    1