Description of Event or Problem · 0
IT WAS REPORTED THAT THE CRYOGEN ICD ON THE CLARITY II DEVICE WAS SHOOTING INTERMITTENTLY DURING TREATMENT. NO PATIENT INJURY OCCURRED. A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO THE TREATMENT SITE FOR A DEVICE EVALUATION. WHEN THE FSE ARRIVED, THEY WERE INFORMED THAT WHILE USING THE INTELLITRAK, THE DEVICE INTERMITTENTLY SWITCHES FROM READY MODE TO STANDBY MODE BY ITSELF. THE DEVICE WAS SUBJECTED TO FULL FUNCTIONALITY TESTING WITH PASSING RESULTS. FSE WAS UNABLE TO DUPLICATE THE REPORTED ISSUES AND THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. THE DEVICE WAS FOUND TO BE WORKING TO PUBLISHED SPECIFICATIONS. AS A PRECAUTION THE HANDPIECE WAS REPLACED. AN INTERNAL INSPECTION OF THE HOSES AND CONNECTIONS TO ENSURE THERE WAS NO INTERNAL LEAKAGE WAS COMPLETED WITH NO DISCREPANCIES OBSERVED. ADDITIONALLY, FSE SHOWED THE CUSTOMER HOW TO PROPERLY CHANGE ICD. CYNOSURE LUTRONIC CLINICAL TEAM CONFIRMED THERE WERE NO PATIENT OR USER INJURY. THIS EVENT IS REPORTABLE UNDER FDA MEDICAL DEVICE REPORTING REQUIREMENTS (21 CFR PART 803), AS IT INVOLVES AN OBSERVED DEVICE MALFUNCTION THAT COULD POTENTIALLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE ISSUE WERE TO RECUR.