ITERO ELEMENT 5D US SYSTEM

Additional Manufacturer Narrative

THE "ELEMENT 5D" WAND IS DESIGNED WITH MULTIPLE BUILT-IN SAFETY MECHANISMS THAT CONTINUOUSLY MONITOR ITS OPERATIONAL STATE. THESE SYSTEMS COVER ALL RELEVANT FAULT CONDITIONS, INCLUDING OVERHEATING, COMPONENT FAILURE, AND ABNORMAL BEHAVIOR. IF ANY FAULT IS DETECTED, THE WAND AUTOMATICALLY SHUTS DOWN TO PREVENT UNSAFE OPERATION. IN ADDITION TO REAL-TIME MONITORING, THE WAND WITH FULL ITERO SCANNING SYSTEM DESIGN IS TESTED AND APPROVED TO CONFORM MEDICAL ELECTRICAL SAFETY 60601-1 INCLUDING SINGLE FAULT CONDITIONS SIMULATION. THESE TESTS CONFIRMED THAT EVEN IN THE PRESENCE OF A FAULT, THE DEVICE DOES NOT REACH TEMPERATURES THAT COULD CAUSE BURNS OR POSE A SAFETY RISK TO THE USER.. THIS EVENT IS BEING FILED AS AN MDR AS THE USER EXPERIENCED A MINOR INJURY ON HAND, WITH NO MEDICAL INTERVENTION NEEDED, AND THE ALIGN TECHNOLOGY, LTD MEDICAL DEVICE WAS BEING USED. A SUPPLEMENTAL REPORT MAY BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE CLINIC AND THE CLINIC ASSISTANT REPORTED THAT AT THE MOMENT OF THE EVENT, THE SCANNER WAS OVERHEATING, AND THE ASSISTANT'S HAND WAS HURT. NO MEDICAL INTERVENTION WAS REQUIRED AND NO CLINICAL LAB/TESTING WAS PERFORMED.