Description of Event or Problem · 0
IT WAS REPORTED THAT DURING CLARITY II TREATMENT THE CRYOGEN WAS SPRAYING CONTINUOUSLY AND RESOLVED ON ITS OWN AFTERWARDS. PROVIDER ALSO MENTIONED THAT THEY WERE NOT SEEING RESULTS WHEN PERFORMING VASCULAR TREATMENTS AND LASER WAS NOT CLEARING THE VEINS CORRECTLY. CYNOSURE LUTRONIC (CL) CLINICAL TEAM CONTACTED THE SITE TO INVESTIGATE THE EVENT. CL CLINICAL CONFIRMED THAT NO INJURY HAD OCCURRED. A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO THE TREATMENT PROVIDER SITE TO PERFORM A DEVICE EVALUATION. FSE PERFORMED METER VERIFICATION IN ALL OPERATIVE MODES. ALL AVAILABLE WINDOWS, FIBERS, AND OPTICS ON ALL CARTRIDGES WERE INSPECTED. ICD OPERATION WAS VERIFIED. COOLANT LEVEL WAS CHECKED, AND THE AIR FILTER WAS CLEANED. BURN SAMPLES WERE RECORDED OF ALL CARTRIDGE SIZES. FULL FUNCTION TEST IN ALL OPERATIVE MODES. DEVICE CONFIRMED TO BE OPERATING WITHIN CYNOSURE LUTRONIC PUBLISHED SPECIFICATIONS. THE EVENT IS REPORTABLE PER FDA MEDICAL DEVICE REPORTING TITLE 21 CFR PART 803 SINCE AN OBSERVED MALFUNCTION OCCURRED AND COULD LIKELY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.