BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIDEK GREEN LASER PHOTOCOAGULATOR.

    MDR report key: 3217373 · Received June 12, 2013

    Report

    Report Number
    3002807715-2013-00001
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    June 16, 2011
    Report Date
    June 7, 2013
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    GEX
    PMA / PMN Number
    K032085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR IN (B)(4) VIA A DISTRIBUTOR. AS A RESULT OF HAVING INVESTIGATED A DEVICE TO THE MFR IN (B)(4), THERE WAS NO MALFUNCTION. THE DEVICE WAS RETURNED TO THE DISTRIBUTOR. WE CONCLUDED THAT IT IS LIKELY TO BE THE PROBLEM BY THE USER HANDLING FACTOR. WE HAVE NO REPORTED DEVICE MALFUNCTION CAUSING OR CONTRIBUTING TO REPORTED ADVERSE EVENT FROM (B)(6) 2011 TO PRESENT DATE. IF FURTHER INFORMATION IS RECEIVED, WE WILL SUBMIT A FOLLOW UP.

    Description of Event or Problem · 1

    ON (B)(6) 2011 NIDEK CO., LTD. OBTAINED THE INFORMATION OF SOME PROBLEMS BELOW RELATED TO GYC-1000 INSTALLED AT (B)(6) FROM (B)(4) DISTRIBUTOR. THE ENGINEER OF THE DISTRIBUTOR SAID THAT "OUTPUT POWER IS UNSTABLE AND FLUCTUATED. AFTER SHOOTING FOR A WHILE, THE POWER ALL OF A SUDDEN BECOME VERY HIGH, AND CAUSED OVER BURN, IT IS VERY DANGEROUS, ONE DAY IT MIGHT SHOOT THROUGH AND CAUSED BLINDNESS TO THE PATIENTS. ADVERSE EVENT BY THIS DOES NOT OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266110 NIDEK GREEN LASER PHOTOCOAGULATOR. NONE GEX NIDEK CO., LTD. GYC-1000

    Patients

    Seq Age Sex Outcome Treatment
    1