BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDART 435

    MDR report key: 2677762 · Received July 18, 2012

    Report

    Report Number
    8021543-2012-04460
    Event Type
    Other
    Date Received
    July 18, 2012
    Date of Event
    October 24, 2011
    Report Date
    June 12, 2012
    Manufacturer
    MEDART A/S
    Product Code
    GEX
    PMA / PMN Number
    K993815
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DATED 11/11/2011. UPON INCOMING INSPECTION, CUSTOMER COMPLAINT WAS CONFIRMED. LASER WAS TESTED FOR OUTPUT POWER AND MEASUREMENT CONFIRMED THAT INITIAL POWER EMITTED WAS APPROX 20% OVER SET VALUE OF 90W AT THE TIME OF INITIAL LASER ACTIVATION. AFTER THE INITIAL POWER OVERSHOT, OUTPUT POWER FELL TO 95W, OR APPROX 5% OVER SET VALUE. THE INTERNAL FEED-BACK MIRROR WAS REPLACED, LASER WAS RE-TESTED AND CALIBRATED. THE INTERNAL POWER METER WAS RE-CALIBRATED AND TESTED. FOLLOWED BY A COMPLETE SYSTEM TEST. LASER WITH ACCESSORIES WAS RETURNED TO THE CUSTOMER. IN AN E-MAIL F/U INQUIRY TO (B)(4), DATED JANUARY 9, 2012, MEDART DID RECEIVE A RESPONSE THAT INDICATED THE LASER WAS WORKING CORRECTLY. IN THE SAME MAIL IT WAS ALSO INDICATED THAT THE PT DID NOT HAVE ANY FURTHER COMPLAINTS. WE ARE TODAY AWAITING THE FINAL REPORT FROM THE DOCTOR. THIS REPORT WILL BE SUBMITTED AS SOON AS READY.

    Description of Event or Problem · 1

    A PT UNDERWENT TREATMENT FOR SUPERFICIAL VEINS ON THE LEG WAS REPORTED HAVING BLISTERS AFTER THE PROCEDURE. THE DOCTOR WAS SUSPECTING TOO HIGH OUTPUT POWER FROM THE DEVICE - A LASER SYSTEM 435 - TO BE A PART OF THE REASON FOR THE BLISTERING. THE (B)(4) WAS CALLING TO MEDART ON (B)(4) 2011, AND WAS REQUESTING RETURN AUTHORIZATION FOR THE LASER EQUIPMENT FOR THE PURPOSE OF TEST AND RE-CALIBRATION OF THE DEVICE. THE DEVICE MODEL 43500, SN (B)(4), WAS SOLD TO (B)(4) ON (B)(4) 2010. NO PRIOR SERVICE HISTORY. THIS IS DEEMED A ONE-OFF ABNORMALITY - NO OTHER SIMILAR LASER SYSTEMS HAVE REPORTED THE SAME ISSUE. ISSUE IDENTIFIED AS A POWER MONITOR MIRROR ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDART 435 435 GEX MEDART A/S 435000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other