Description of Event or Problem · 0
IT WAS REPORTED THAT PATIENT EXPERIENCED A BURNING SENSATION AND A VISIBLE MARK APPEARED ON PATIENT'S SKIN FOLLOWING A TREATMENT USING XERF. SITE ALSO RELAYED THAT TREATMENT WAS PERFORMED AT LEVEL 7 AFTER 20 PULSES. CYNOSURE LUTRONIC (CL) CLINICAL TEAM CONTACTED THE SITE TO INVESTIGATE THE EVENT. CL CLINICAL DETERMINED THE EVENT TO BE INCONCLUSIVE. PATIENT'S TREATMENT COULD NOT BE COMPLETED WITH 100 PULSES REMAINING IN THE TREATMENT AREA. TREATMENT WAS STOPPED AFTER PATIENT COMPLAINED OF BURNING SENSATION. IMAGES OF THE EFFECTOR TIP WERE PROVIDED. PER CL CLINICAL, "THE EFFECTOR TIP APPEARS TO HAVE A SCORCHED AREA. IT CANNOT BE CONFIRMED IF THE EFFECTOR WAS DEFECTIVE, OR DURING THE CLEANING PROCESS AND REMOVING THE EFFECTOR FROM THE PACKAGE IT WAS DAMAGED." CL CLINICAL REMINDED SITE OF PROPER CARE OF THE EFFECTOR PER LABELING. XERF EFFECTOR TIP HAS NOT YET BEEN RETURNED FOR A DEVICE EVALUATION, BUT A PHOTO WAS PROVIDED DURING INITIAL COMMUNICATION. SURFACE DAMAGE WAS OBSERVED ON THE TIP. ONCE TIP HAS BEEN RETURNED AND EVALUATED, A CYNOSURE FIELD SERVICE ENGINEER (FSE) CAN DETERMINE ROOT CAUSE. 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. WE ARE REPORTING THIS AS AN INITIAL MDR AND WILL SUBMIT A FINAL MDR ONCE INVESTIGATION HAS BEEN COMPLETED.