BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASCAL PHOTOCOAGULATOR

    MDR report key: 919286 · Received March 23, 2007

    Report

    Report Number
    3005675890-2007-00001
    Event Type
    Malfunction
    Date Received
    March 23, 2007
    Date of Event
    February 22, 2007
    Report Date
    February 22, 2007
    Manufacturer
    OPTIMEDICA CORPORATION
    Product Code
    GEX
    PMA / PMN Number
    k043486
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ENGINEER VISITED THE SITE ON 3/22/2007 AND EXAMINED THE DEVICE. THE DEVICE CALIBRATION WAS FOUND OUT OF SPEC, WHICH CONTRIBUTED TO THE ALARM BEEPING BUT IS NOT THE ROOT CAUSE FOR THE BLEEDING. THE ROOT CAUSE OF THE ADVERSE EVENT COULD NOT BE DETERMINED. FINDING: AUDIBLE ALARM WAS CAUSED BY THE DEVICE BELIEVING THAT IT SENSED A +20% POWER OUTPUT ON THE LIO. THE ACTUAL LIO POWER OUTPUT WAS MEASURED SLIGHTLY ABOVE SPEC BUT WELL BELOW THE +20% LIMIT. THE REASON FOR THE +20% ALARM SOUNDING WAS THAT BACK-REFLECTANCE IN THE LIO FIBER OPTIC CAUSED THE SENSOR TO MEASURE MORE LASER LIGHT THAN WAS ACTUALLY GENERATED. FINDING: ACTUAL POWER OUTPUT OF THE DEVICE WITH THE LIO VARIED SLIGHTLY OUT OF SPEC. THE LASER HEAD AND LASER CONTROLLER BOARD WERE REPLACED. THE DEVICE WAS THEN RETESTED AND FOUND TO BE WELL WITHIN THE DEVICE SPEC. CONCLUSION: NEITHER FINDING #1 OR FINDING #2 COULD HAVE CAUSED THE ADVERSE EFFECT IN THE PT BECAUSE THE LASER POWER LEVEL USED WAS TOO LOW AND THE DURATION PERIOD WAS TOO SHORT. THESE FINDINGS WERE ALSO DISCUSSED WITH AN INDEPENDENT RETINA SPECIALIST WHO CONCURRED THAT THE EVENT OF THE RETINAL BLEEDING COULD NOT BE ASSOCIATED WITH THE USE OF LOW LASER POWER SETTINGS AND SHORT PULSE DURATIONS. THE ACTUAL ROOT CAUSE FOR THE ADVERSE EVENT COULD NOT BE DETERMINED. EVAL SUMMARY: PASCAL PHOTOCOAGULATOR. INTRODUCTION: AT APPROX 9:30 AM IN 2007, OPTIMEDICA REC'D NOTIFICATION THAT AN ADVERSE EVENT HAD OCCURRED AT A CUSTOMER'S FACILITY. OPTIMEDICA DISPATCHED AN ENGINEER WHO ARRIVED ON THE CUSTOMER'S SITE AT 3:30 PM SAME DAY (I.E. 2007). EVAL OF THE DEVICE'S INTERNAL LOGS: THE TREATMENT LOG SHOWED THAT THE DR FIRED MULTIPLE SINGLE SHOTS, ALL UTILIZING THE LIO AND ALL BUT ONE OF THEM AT 150MW WITH A 20 MS PULSE DURATION (THE FIRST SHOT WAS AT 200 MW). REPEAT MODE WAS SET AT 3HZ FOR MOST OF THE SHOTS. THE ERROR LOG SHOWED THAT THE SAME NUMBER OF +20% OVER POWER ERRORS OCCURRED IN THE SAME TIMEFRAME, MEANING THAT EACH SHOT MADE BY THE DR TRIGGERED A +20% POWER ERROR ALARM. EVAL OF DEVICE PERFORMANCE: THE ENGINEER ATTEMPTED TO TAKE ACTUAL POWER MEASUREMENTS OF THE LIO OUTPUT WITH THE DEVICE IN "USER MODE", BUT WOULD HEAR AN ALARM BEEP AND THE LASER WOULD TURN OFF DURING THE TREATMENT CYCLE. EVEN AT DIFFERENT POWER SETTINGS, THE SAME RESULT (I.E. AN ALARM BEEP AND THE LASER STOPPED MID-CYCLE) WOULD OCCUR. THE ENGINEER REPEATED THE TEST USING THE SLIT LAMP AND FOUND THAT THE DEVICE PERFORMED NORMALLY (I.E. NO ALARM BEEP AND THE LASER WOULD COMPLETE THE TREATMENT CYCLE). USING THE "CALIBRATION MODE", THE ENGINEER WAS ABLE TO MEASURE THE ACTUAL POWER OUTPUT FROM THE LASER INDIRECT OPHTHALMOSCOPE (LIO) FOR VARIOUS EQUIPMENT POWER SETTINGS. THE DEVICE'S ACTUAL POWER OUTPUT MEASUREMENTS SHOWED A VARIATION SLIGHTLY ABOVE DESIGN SPEC. BECAUSE THE LASER SUBSYSTEM WAS PERFORMING OUT OF SPEC (EVEN THOUGH JUST SLIGHTLY), IT WAS DECIDED TO REPLACE IT. THE LASER DECK (CONSISTING OF THE LASER HEAD AND ITS ASSOCIATED OPTICS) AND THE LASER CONTROLLER BOARD WERE REPLACED AND THE SYSTEM WAS CALIBRATED. AFTER THE DEVICE WITH NEW LASER WAS CALIBRATED, IT CONTINUED TO HAVE +20% ALARM BEEPS. ADD'L TESTING DETERMINED THAT BACK-REFLECTANCE FROM THE LIO CABLE WAS REFLECTING SOME OF THE LASER LIGHT BACK INTO THE SENSOR THAT MEASURES THE LIGHT GENERATED BY THE LASER. WHEN THE BACK-REFLECTED LIGHT IS ADDED TO THE NORMAL LASER POWER, THE OUTPUT POWER AS REGISTERED BY THE SENSOR WOULD BE HIGH ENOUGH TO TRIGGER A FALSE +20% ALARM BEEP. IN ORDER TO ADEQUATELY TEST THE LASER INDIRECT OPHTHALMOSCOPE (LIO) ITSELF, IT WAS DECIDED TO BRING THE LIO BACK TO THE OPTIMEDICA FACTORY (SANTA CLARA, CA) FOR ADD'L TESTING AND ANALYSIS. FOLLOW-UP: THE LIO WAS THOROUGHLY TESTED IN THE FACTORY AND WAS DETERMINED TO BE IN PROPER WORKING ORDER. NO REPAIRS OR ADJUSTMENTS WERE MADE TO THE LIO. ON MARCH 2, 2007, THE ENGINEER RETURNED TO THE CUSTOMER SITE AND CONFIRMED THAT THE DEVICE WAS OPERATING PROPERLY. HE THEN REINSTALLED THE ORIGINAL LIO AND THE DEVICE WAS RECALIBRATED WITH BACK-REFLECTANCE BEING COMPENSATED FOR. WHEN THE ENGINEER LEFT THE CUSTOMER SITE, THE PASCAL DEVICE WITH THE LIO WAS OPERATING PROPERLY AND WITHIN DEVICE SPECS.

    Description of Event or Problem · 1

    DR TREATED PT FOR A PERIPHERAL RETINAL TEAR IN THE LEFT EYE UTILIZING A PASCAL PHOTOCOAGULATOR EQUIPPED WITH A LASER INDIRECT OPHTHALMOSCOPE (LIO). DURING THE TREATMENT, THE DR. FIRED THE LASER SEVERAL TIMES, EACH TIME HE OBSERVED A SMALL AMOUNT OF BLEEDING AROUND THE TREATMENT SPOT AND HEARD AN ALARM BEEP FROM THE DEVICE. HE APPLIED PRESSURE TO THE EYE TO STOP THE BLEEDING. AFTER THE BLEEDING WAS CONTROLLED, THE DR COMPLETED THE PT'S TREATMENT UTILIZING A DIFFERENT LASER DEVICE WITH A HIGHER POWER LEVEL AND A LONGER PULSE DURATION. THE PT'S TREATMENT WAS COMPLETED WITHOUT ANY ADD'L BLEEDING. THE PT DID REPORT SEEING "FLOATERS" FOR A FEW DAYS AFTER THE PROCEDURE UNTIL THE BLOOD WAS REABSORBED FROM THE VITREOUS CAVITY. THE DR RE-EXAMINED THE PT IN 2007, AND REPORTED FINDING NO RESIDUAL DAMAGE AND OBSERVED NO SIDE EFFECTS FROM THE TREATMENT. IT IS UNK IF THE SMALL AMOUNT OF BLEEDING WAS RELATED TO THE USAGE OF THE PASCAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASCAL PHOTOCOAGULATOR GEX GEX OPTIMEDICA CORPORATION PASCAL-US *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other