Description of Event or Problem · 0
IT WAS REPORTED THAT A PATIENT EXPERIENCED A BURN ON THE FOREHEAD AND NOSE FOLLOWING A TREATMENT USING ELITE IQ. PATIENT WAS GIVEN AQUAPHOR, BACITRACIN, AND PREDNISONE AS PREVENTATIVE MEDICATION POST TREATMENT. SETTINGS ON FOREHEAD BETWEEN BROWS WAS LHR 1064NM YAG 12MM SPOT 30JCM2 20MS, AND ON THE NOSE WAS 2.5MM 120 J/CM2 30MS. OPERATOR ALSO NOTED ZIMMER HOSE WAS NOT CONNECTING PROPERLY AND WANTED A DEVICE EVALUATION. A SERVICE EVALUATION WAS PERFORMED WITH CYNOSURE FIELD SERVICE ENGINEER (FSE) CONFIRMING ZIMMER HOSE AT HANDPIECE END WAS DAMAGED AND BEING HELD TOGETHER BY TAPE. THE TAPE WAS SQUEEZING THE ZIMMER HOSE AND COULD BE RESTRICTING AIRFLOW AND AFFECTING THE SKIN COOLING EFFICIENCY. FSE RELAYED TO SITE THAT HOSE SHOULD HAVE BEEN REPLACED. POWER OUTPUT WAS CONFIRMED TO BE WITHIN SPECIFICATION AND WAS NOT THE REASON FOR THE BURNS EXPERIENCED. CYNOSURE CLINICAL REACHED OUT TO THE SITE FOR ADDITIONAL INFORMATION. IMAGES OF THE PATIENT WAS ALSO PROVIDED AND SHOWED PATIENT MAY HAVE RECEIVED POTENTIAL SUN EXPOSURE BEFORE OR AFTER TREATMENT. SITE ALSO RELAYED THAT ONE OF THE TREATMENTS WAS PERFORMED WITH TOO MUCH OVERLAP. PER CYNOSURE CLINICAL, "IT IS UNKNOWN IF OVERLAP CONTRIBUTED TO THE BURNS." THE BURN EXPERIENCED WAS CONFIRMED BY CYNOSURE'S MEDICAL DIRECTOR TO BE A SMALL THICKNESS BURN BETWEEN THE EYEBROWS. CYNOSURE'S MEDICAL DIRECTOR RECOMMENDED TO CLEANSE 2-3 TIMES A DAY, APPLY A THIN LAYER OF AQUAPHOR, AND AVOID SUN EXPOSURE. ALSO, CYNOSURE'S MEDICAL DIRECTOR'S OPINION WAS THAT PREDNISONE WAS NOT NECESSARY. BURNS ARE AN EXPECTED SIDE EFFECT FROM SUCH TREATMENT. SINCE A FULL THICKNESS BURN OCCURRED FROM THIS EVENT, THIS IS CONSIDERED A SERIOUS INJURY AND THEREFORE REPORTABLE.