Description of Event or Problem · 0
IT WAS REPORTED THAT THE CLARITY II DEVICE HANDPIECE WAS IN THE HOLSTER AND NOT IN USE WHEN IT FIRED ON ITS OWN. THE HANDPIECE (HP) CARTRIDGE CASE WAS DAMAGED DUE TO THE MISFIRE. CLINICAL CONFIRMED THERE WERE NO INJURIES REPORTED TO THE PATIENT OR USER. A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER WENT TO THE CUSTOMER SITE FOR A DEVICE EVALUATION. DURING THIS TIME THE DEVICE, THE DEVICE HP AND DEVICE FOOT PEDAL WERE ALL SUBJECTED TO FULL FUNCTIONALITY TESTING AND VISUAL INSPECTION WITH PASSING RESULTS. THE REPORTED ISSUE OF DEVICE MISFIRING WAS UNABLE TO BE DUPLICATED. HOWEVER, DAMAGE OBSERVED TO THE LASER SHOWS EVIDENCE THAT THE DEVICE MISFIRED WAS NOTED. THE DAMAGE IS CONSISTENT WITH THE HP NOT BEING PLACED IN THE HP HOLSTER CORRECTLY CAUSING THE HP BUTTON TO BE ENGAGED AND THE HP TO FIRE. TO CORRECT THIS DAMAGE, THE CARTRIDGE CASE WAS REPLACED AND THE FSE DISCUSSED PROPER HP PLACEMENT WITH THE CUSTOMER TO REDUCE THE PROBABILITY OF REOCCURRENCE. IT IS UNDETERMINED WHAT CAUSED THE REPORTED MISFIRING. TO REDUCE THE PROBABILITY OF RECURRENCE THE CLINICAL TEAM REVIEWED WITH THE TREATMENT PROVIDER SAFE PRACTICES, INCLUDING PUTTING THE DEVICE ON STANDBY BEFORE PUTTING THE HANDPIECE IN THE CRADLE TO PREVENT MISFIRING. SINCE A REPORTED MALFUNCTION OCCURRED AND THERE IS POTENTIAL SERIOUS INJURY, WE ARE REPORTING THIS AS AN ARO EVENT.