BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASCAL SYNTHESIS 532/577

    MDR report key: 6247201 · Received January 12, 2017

    Report

    Report Number
    3008599994-2016-00003
    Event Type
    Injury
    Date Received
    January 12, 2017
    Date of Event
    November 28, 2016
    Report Date
    December 2, 2016
    Manufacturer
    TOPCON MEDICAL LASER SYSTEMS INC.
    Product Code
    HQF
    PMA / PMN Number
    K123542
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ANALYSIS OF THE SYSTEM LOG BY TMLS R AND D - IT WAS CONFIRMED THAT THE LOG FILE, CALIBRATION DATA, ALARM SETTING AND TREATMENT DATABASE ARE ALL FUNCTIONING ACCORDING TO SPECIFICATIONS. FURTHER INVESTIGATION NEEDED. PLACE OF EVENT: (B)(6) HOSPITAL.

    Description of Event or Problem · 1

    FIELD SERVICE ENGINEER RECEIVED A CALL FROM A CUSTOMER REGARDING PASCAL SYNTHESIS. S. NO. (B)(4). AS REPORTED BY THE FIELD SERVICE ENGINEER, THE CALLER STATED AS FOLLOWS: "A PATIENT WHILE RECEIVING TREATMENT STARTED TO SHOUT BECAUSE HE OVERCOOKED THE PATIENT'S RETINA. HE IMMEDIATELY LOWERED THE POWER FROM 200MW TO 150MW AND THEN TO 100MW AND TIME EXPOSURE FROM 20MS TO 15MS." AS REPORTED - THE LASER WAS USED WITH THE FOLLOWING CONFIGURATION TO TREAT A PATIENT: 200MS PATTERNS; POWER 200MW; EXPOSURE 20MS; SPOT DIAMETER 200UM; SPOT SPACING 1.50; EPM OFF; 37 SPOTS. THE USER STATED THAT HE DIDN'T GET ANY ERROR MESSAGES REGARDING THE POWER BEING OVER EXPECTED ALTHOUGH HE MENTIONED THAT IN THE INFORMATION WINDOW HE GOT 1.332 WRITTEN IN YELLOW NEXT TO DEFAULT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION TO PREVIOUSLY SUBMITTED MDR ON 12/02/2016. THE SYSTEM WAS INVESTIGATED AND WAS FOUND TO BE WORKING IN ACCORDANCE WITH SPECIFICATIONS. THE EVENT ON (B)(6) 2016 IS SUSPECTED TO HAVE BEEN CAUSED BECAUSE OF ERROR ON THE USER'S PART. THE TREATMENT PARAMETERS CHOSEN BY THE PHYSICIAN ARE EXPECTED TO CAUSE PAIN. THE PATIENT IS NOT EXPERIENCING ANY ADVERSE EFFECTS AS A RESULT OF THIS INCIDENT, AS REPORTED BY TOPCON ((B)(4)) REPRESENTATIVE - AFTER VISITING THE SITE AND INVESTIGATING THE ISSUE. THE YELLOW DEFAULT MESSAGE OBSERVED AS BECAUSE THE CLINICIAN WAS NOT HOLDING DOWN THE FOOTSWITCH FOR LONG ENOUGH, LEADING TO AN INCOMPLETE PATTERN DELIVERY. THIS CAUSED THE ODD SHAPED PATTERN DELIVERIES OBSERVED ON THE DAY, AND THE ZIG ZAG LINE PATTERN WHEN THE PATIENT MOVED. THE CLINICIAN WAS TRAINED ON 12/09/2016. AN ADDITIONAL TRAINING IS SCHEDULED FOR 01/18/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30653 PASCAL SYNTHESIS 532/577 PASCAL SYNTHESIS HQF TOPCON MEDICAL LASER SYSTEMS INC. SA-06280

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R