Description of Event or Problem · 0
IT WAS REPORTED PATIENT EXPERIENCED BURNS, BLISTER, AND SCABBING POST TREATMENT USING ELITE IQ. PATIENT HAVE HEALED WITH DIVOTS IN AREAS WHERE SCABBING WAS. PATIENT DID NOT INFORM SITE ABOUT ADVERSE EFFECTS AND ONLY RELAYED THIS DURING FOLLOW UP APPOINTMENT. CYNOSURE CLINICAL TEAM INVESTIGATED THE EVENT AND DETERMINED USER ERROR WAS INVOLVED. PER CYNOSURE CLINICAL'S ASSESSMENT, "THE FLUENCE WAS TOO HIGH AND THE PULSE WIDTH TOO SHORT, ALONG WITH THE POSSIBILITY OF DOUBLE PULSING. ALL OF THESE ARE KNOWN TO CAUSE BLISTERING AND SCABBING AS STATED IN THE CLINICAL REFERENCE GUIDE." CYNOSURE CLINICAL ALSO RELAYS DIVOTS ARE CONSISTENT WITH SCARRING. BURNS AND BLISTERS ARE EXPECTED SIDE EFFECTS FROM SUCH TREATMENT. CYNOSURE FIELD SERVICER ENGINEER (FSE) ARRIVED ON SITE AND EVALUATED THE DEVICE. FSE OBSERVED 5MM AND 18MM HANDPIECES HAD BURN SPOTS ON INTERNAL LENSES AND REQUESTED TECH SUPPORT TO SEND AN ESTIMATE FOR REPAIR. FSE CONFIRMED DEVICE WAS OPERATING WITHIN MANUFACTURER SPECIFICATIONS. SINCE DIVOTS ARE CONSISTENT WITH SCARRING, THIS IS CONSIDERED A PERMANENT INJURY AND THEREFORE REPORTABLE.