BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASCAL SYNTHESIS 532NM

    MDR report key: 7266990 · Received February 13, 2018

    Report

    Report Number
    3008599994-2017-00001
    Event Type
    Malfunction
    Date Received
    February 13, 2018
    Date of Event
    October 31, 2017
    Report Date
    November 17, 2017
    Manufacturer
    TOPCON MEDICAL LASER SYSTEMS, INC.
    Product Code
    HQF
    PMA / PMN Number
    K123542
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCAL FSE FAILED TO DOCUMENT OR PERFORM SYSTEM INSTALLATION AND CALIBRATION, IN ACCORDANCE WITH MANUFACTURER'S INSTRUCTIONS AND REQUIREMENTS.

    Description of Event or Problem · 1

    COMMENTS FROM THE END-USER: "I TRIED TO TREAT A PATIENT SUFFERING FROM PANRETINAL PHOTOCOAGULATION-PRP WITH THE MULTISPOT LASER. I USED 200 UM SPOT SIZE.20MS EXPOSURE TIME, 9 SIZE PATTERN AND 0.5 IN SPACING. I STARTED WITH 200MW POWER. THIS RESULTED IN VERY POWERFUL LASER EFFECTS AND THE PATIENT GOT SEVERE PAIN. I LOWERED THE POWER STEP BY STEP TO 180MW, 160MW, 120MW, 100MW, 80MW, 60MW AND 40MW BUT THE EFFECTS WERE AS POWERFUL AND PAINFUL AS THE FIRST ONE. AT LAST AT POWER 20MW I GOT AN ALERT SAYING "TREATMENT LOCAL SLIGHTLY OVER EXPECTED" OR SOMETHING LIKE IT. I CANCELLED THE TREATMENT AND MOVED TO ANOTHER LASER." THIS UNIT WAS FIRST INSTALLED ON (B)(6) WITH A D7 SLIT LAMP. LASER WAS PERFORMING FINE, BUT THE DOCTLOR DID NOT LIKE THE SLIT LAMP- SO A HAAG-STREIT SLIT LAMP WAS INSTALLED ON (B)(6) AND THE SYSTEM WAS CALIBRATED. AFTER THE INCIDENT WAS REPORTED, THE LOCAL FIELD SERVICE ENGINEER VISITED THE SITE AND WSS ABLE TO CONFIRM THAT THE TREATMENT POWER OUTPUT FROM THIS SYSTEM IS TOO HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111606 PASCAL SYNTHESIS 532NM OPHTHALMIC SCANNING LASER SYSTEM HQF TOPCON MEDICAL LASER SYSTEMS, INC. SA-06286

    Patients

    Seq Age Sex Outcome Treatment
    1 Other