Description of Event or Problem · 0
ON (B)(6) 2026, THERE WAS AN ACCIDENTAL RADIATION OCCURRENCE INVOLVING THE ALIYA (EPILME) DEVICE (K213261), MANUFACTURED BY NEAUVIA NORTH AMERICA. HERE IS A RUNDOWN OF WHAT HAPPENED: INSTALLED NEW HANDPIECE. TURNED MACHINE ON, IT PASSED STARTUP TESTS AND TURNED ON NORMALLY. BROUGHT BACK PATIENT, SHE WAS SCHEDULED TO TREAT MULTIPLE AREAS. STARTED WITH UPPER LIP - SELECTED BASIC MODE, INPUT PATIENT SETTINGS AND PUT LASER IN STAMP MODE. FIRST PULSE FIRED FINE, WENT TO PULL TRIGGER FOR SECOND PULSE TO LIP AND NOTHING HAPPENED. REMOVED LASER FROM PATIENT, FINGER WAS NOT ON TRIGGER, AND IT FIRED INTO THE AIR. RESTARTED LASER. TESTED ON MY FOREARM AND SAME THING HAPPENED, LET ME DO FIRST PULSE THEN TRIGGER WAS NOT WORKING. SWITCHED TO PAINT MODE TO TEST. TREATED PATIENT'S RIGHT AXILLA SUCCESSFULLY. WENT TO TREAT LEFT AXILLA AND TRIGGER WAS NOT WORKING OR SHOWING SIGNS OF TREATMENT ON DEVICE. PLACED HANDPIECE BACK IN HOLDER - NO SIGNS OF ACTIVE FIRING (IT WILL MAKE A NOISE DURING ACTIVE TREATMENT AND AT THE BOTTOM SHOW A SLIDING SCALE OF HOW MUCH ENERGY HAS BEEN USED AND WILL STOP ALONG WITH THE NOISE WHEN TREATMENT AREA IS COMPLETE). THE SCREEN WAS FROZEN AND WOULD NOT LET ME BACK OUT OR TURN THE LASER OUT OF ACTIVE MODE (THE LASER WILL NORMALLY IDLE IN ACTIVE MODE WHILE YOU SWITCH AREAS AND COMPLETE ALL SECTIONS OF THE TREATMENT, ONLY FIRING WHILE YOUR FINGER IS ON THE TRIGGER). LET PATIENT KNOW WE WOULD NEED TO RESCHEDULE. I RESCHEDULED THE PATIENT IN THE ROOM AND WALKED HER OUT AND LET THE FRONT DESK KNOW THEY WOULD NEED TO CALL MY FIRST FEW PATIENTS WHILE I DID SOME TROUBLESHOOTING. WALKED BACK TO ROOM AND NOTICED THE SMOKE/BURNING, TURNED MACHINE OFF COMPLETELY AND UNHOOKED HANDPIECE FROM DEVICE. REGARDLESS OF THE SCENARIO, IT SHOULD NOT HAVE BEEN FIRING WITHOUT SOMEONE'S FINGER ON THE TRIGGER. ALSO, I DON'T HAVE THE FOOT PEDAL HOOKED UP, SO IT COULDN'T HAVE BEEN A FIRING ISSUE WITH THAT. THE TIME PRIOR THAT THE HANDPIECE BROKE IT STARTED FROSTING OVER A COUPLE OF MINUTES BEFORE IT GAVE THE ERROR MESSAGE. ANY GEL OR DISINFECTING WIPES THAT WOULD TOUCH IT WOULD IMMEDIATELY FROST OVER.