Description of Event or Problem · 0
IT WAS REPORTED THAT DURING TREATMENT WITH A XERF 2.0 DEVICE, THE PATIENT EXPERIENCED SEVERAL BURN SPOTS ON THE FACE. IT WAS ALSO OBSERVED THAT THE EFFECTOR 60 TIP HAD A CIRCULAR SCORCHED AREA. A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER PAID A VISIT TO THE TREATMENT FACILITY FOR A DEVICE EVALUATION. DURING THIS TIME THE DEVICE WAS INSPECTED, AND THERE WAS NO APPARENT DAMAGE TO THE DEVICE. THE DEVICE WAS ALSO SUBJECTED TO FULL FUNCTIONALITY TESTING WITH PASSING RESULTS. THE ENERGY LEVELS AND SETTINGS WERE CHECKED AND VERIFIED TO BE WORKING WITHIN SPECIFICATIONS. IT IS UNDETERMINED THE EXACT ROOT CAUSE OF THIS INCIDENT. ADDITIONALLY, THE HANDPIECE WAS ALSO EVALUATED AND FOUND TO BE WORKING WITHIN ITS SPECIFICATIONS. AS A PRECAUTION, THE O-RING WAS REPLACED, AND THE DEVICE WAS CONCLUDED TO BE WORKING WITHIN ITS SPECIFICATIONS. THE FSE ALSO REPLACED THE DAMAGED EFFECTOR TIP WHICH WILL BE SHIPPED TO THE MANUFACTURER FOR FURTHER EVALUATION AND INVESTIGATION. THE CAUSE OF THE DAMAGE OBSERVED TO THE TIP CANNOT BE DETERMINED AT THIS TIME. ROOT CAUSE WILL BE DETERMINED AFTER THE TIP HAS BEEN RECEIVED AND EVALUATED BY THE MANUFACTURER. A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM FOLLOWED UP WITH THE TREATMENT PROVIDER AND CONFIRMED THAT THE PATIENT WAS HEALING WELL. 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.