Description of Event or Problem · 0
IT WAS REPORTED THAT CRYOGEN WAS LEAKING OUT OF THE HANDPIECE (HP) DURING A XERF TREATMENT. TREATMENT WAS DISCONTINUED WHEN THE ISSUE OCCURRED. THE PATIENT REPORTED REDNESS ON THE SKIN. A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM CONTACTED THE TREATMENT CLINIC AND REQUESTED ADDITIONAL INFORMATION ABOUT THE TREATMENT TO ASSIST WITH THE INVESTIGATION INCLUDING TREATMENT PARAMETERS USED, PRE AND POST TREATMENT CARE, ANY PRE OR POST IMAGES OF THE PATIENT AS WELL AS CONFIRMATION IF THE PATIENT EXPERIENCED A BURN. ALTHOUGH THERE WERE MULTIPLE INFORMATION REQUESTS, THESE INFORMATION REQUESTS WENT UNANSWERED AND IT IS UNKNOWN IF AN INJURY OCCURRED. THE TREATMENT CLINIC PROVIDED A VIDEO OF THE REPORTED ISSUE OF CRYOGEN LEAKING FROM THE HP. IN THIS VIDEO THE CRYOGEN CAN BE OBSERVED LEAKING FROM THE HP. A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO THE TREATMENT CLINIC FOR A DEVICE EVALUATION. DURING THIS TIME THE DEVICE HP WAS REPLACED. FOLLOWING REPAIRS, THE DEVICE WAS TESTED AND FOUND TO BE WORKING TO PUBLISHED SPECIFICATIONS. SINCE THE HANDPIECE WAS LEAKING CRYOGEN, THIS IS CONSIDERED A DEVICE MALFUNCTION. THIS EVENT IS REPORTABLE UNDER FDA MEDICAL DEVICE REPORTING REQUIREMENTS (21 CFR PART 803), AS IT INVOLVES A DEVICE MALFUNCTION THAT COULD POTENTIALLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE ISSUE WERE TO RECUR.