BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREPOINT

    MDR report key: 1220387 · Received October 31, 2008

    Report

    Report Number
    2028159-2008-00397
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 9, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQF
    PMA / PMN Number
    K062624
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO SAMPLES RETURNED FOR EVALUATION. THERE WAS NO ADDITIONAL INFORMATION RELATED TO THIS COMPLAINT PROVIDED AND THE SYSTEM WAS FOUND TO MEET SPECIFICATIONS WHEN EXECUTING THE SERVICE TEST PROCEDURE. THE LASER FIRING TONE ON THE LASER SYSTEM IS NOT DESIGNED TO CORRELATE TO THE RATE AT WHICH THE LASER IS FIRING. THE FACILITY CONTINUED TO USE THE SYSTEM WITH NO PROBLEMS REPORTED. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS REVEALED NO ADDITIONAL COMPLAINTS RELATED TO THE REPORTED EVENT. A REVIEW OF SERVICE REQUESTS FOR THE LAST 24 MONTHS REVEALED NO ADDITIONAL SERVICE REQUESTS RELATED TO THE REPORTED EVENT. A QUESTIONNAIRE WAS SENT TO THE REPORTER ON 10/14/2008, AND FOLLOWED UP ON 10/16/2008 AND 10/24/2008. NO RESPONSE TO THE QUESTIONNAIRE WAS RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 10/31/2008.

    Description of Event or Problem · 1

    THE SURGEON STATED HE FELT THAT THE LASER WAS TOO SLOW AND ASKED FOR THE POWER, DURATION AND INTERVAL TO BE CHANGED. HE FELT THAT THIS WOULD INCREASE HIS LASER SHOTS AS WELL AS THE SPEED. THE SURGEON'S SETTINGS WERE ORIGINALLY 250 MW 200 DURATION 200 INTERVAL. HE WAS USING THE TONE OF THE LASER SYSTEM AS AN INDICATION OF A LASER FIRING RATHER THAN THE FLASH OF THE LASER PULSE. THEREFORE, THE LASER PULSES WERE REPEATED ON THE SAME SPOT SEVERAL TIMES. THE SURGEON THEN ASKED THE TECHNICIAN TO INCREASE HIS POWER TO 350 MW 100 DURATION 100 INTERVAL. THE SURGEON THEN REALIZED THAT THE INTENSITY OF THE LASER WAS GREATLY INCREASED. THE SURGEON REALIZED THAT THE TONE OF THE LASER AND THE FIRING WERE NOT SYNCHRONIZED, AND THAT CONCENTRATION ON THE LASER FLASH IS NECESSARY. THE SURGEON ASKED FOR DECREASE TO 200 MW 200 DURATION 200 INTERVAL, WHICH ALLOWED HIM TO FINISH THE CASE AND COMPLETE THE REST OF THE CASES WITHOUT CONCERN. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUREPOINT LASER, OPHTHALMIC HQF ALCON - IRVINE TECHNOLOGY CENTER PUREPOINT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI