Description of Event or Problem · 0
ACCORDING TO THE REPORT SUBMITTED BY THE DISTRIBUTOR, THE HAND PIECE STARTED FIRING BY ITSELF WHILE IN THE HOLDER AND THE TOUCH SCREEN DISPLAY WOULD NOT RESPOND TO TOUCH. THE SAPPHIRE TIP IS FROSTED OVER AND THE FRONT COVER IS MELTED. THE POWER METER INSIDE THE HAND PIECE HOLDER IS DAMAGED. ADVISED THE CLINIC TO NOT USE THE DEVICE AND RETURN FOR INVESTIGATION BY THE MANUFACTURER. THIS IS AN ISOLATED OCCURRENCE AND NO OTHER COMPLAINTS OF THIS NATURE HAVE BEEN REPORTED. NO INJURIES WERE ASSOCIATED WITH THIS EVENT. TECHNICAL INVESTIGATION DETERMINED THAT THE INCIDENT WAS CAUSED BY A MECHANICAL MALFUNCTION OF THE MICRO-SWITCH USED IN THE APPLICATOR TRIGGER ASSEMBLY. THE MICRO-SWITCH REMAINED IN AN ACTIVATED STATE AFTER THE OPERATOR RELEASED THE HAND TRIGGER, RESULTING IN CONTINUOUS TRIGGER SIGNAL DETECTION BY THE SYSTEM. AS A CONSEQUENCE, THE APPLICATOR CONTINUED EMITTING PULSES UNINTENTIONALLY WHILE POSITIONED IN THE DOCKING AREA. INSPECTION OF THE APPLICATOR INDICATED THAT THE MICRO-SWITCH IN THE TRIGGER MECHANISM HAD LIKELY BECOME MECHANICALLY BLOCKED OR FAILED INTERNALLY, PREVENTING PROPER RETURN OF THE MICRO-SWITCH TO ITS RELEASED POSITION. THE ISSUE WAS REPRODUCED DURING FUNCTIONAL TESTING AND CONFIRMED DURING APPLICATOR INSPECTION. THE MAIN DEVICE IS FUNCTIONING AS INTENDED. THE ISSUE IS ISOLATED TO THE HANDPIECE ONLY. A CAPA INVESTIGATION HAS BEEN OPENED TO IDENTIFY ROOT CAUSE AND HOW TO KEEP THIS EVENT FROM REOCCURRING IN THE FUTURE.