ITERO ELEMENT 2

Additional Manufacturer Narrative

UPDATES WERE MADE AFTER REVIEWING THE QUALITY OF DEVICE IDENTIFICATION INFORMATION SUBMITTED PREVIOUSLY AGAINST DATA IN THE GUDID.

Additional Manufacturer Narrative

NO ADDITIONAL INFORMATION ABOUT THE USER'S CONDITION WAS OBTAINED DESPITE ATTEMPTS TO GATHER THIS INFORMATION, NOR WAS THE DEVICE RETURNED FOR FURTHER INVESTIGATION. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF AVAILABLE PHOTOGRAPHS AND INFORMATION SUPPLIED BY THE USER. ALIGN'S CLINICAL ASSESSMENT OF THE AVAILABLE RECORDS INDICATE THAT THE USER'S HAND INJURY WAS A MINOR, SUPERFICIAL INJURY THAT DID NOT POSE ANY IMMEDIATE RISK TO LIFE, NOR DID IT SUGGEST THE PRESENCE OF SIGNIFICANT TRAUMA LIKELY TO RESULT IN PERMANENT IMPAIRMENT OR DISABILITY. WITH THIS, ALIGN CONCLUDES THAT THE USER SOUGHT HOSPITAL CARE AS A PRECAUTIONARY MEASURE.

Additional Manufacturer Narrative

THE CURRENT USER MANUAL FOR THE ITERO ELEMENT 2 IMAGING SYSTEM CONTAINS THE FOLLOWING ELECTRIC WARNINGS: "DO NOT CONNECT THE SCANNER TO A MAINS SUPPLY WITHOUT PROTECTIVE GROUNDING, IN ORDER TO AVOID THE RISK OF ELECTRICAL SHOCK". THIS EVENT IS BEING FILED AS AN MDR AS THE USER EXPERIENCED A MINOR INJURY ON HAND, REQUIRING VISITING THE EMERGENCY ROOM, AND THE ALIGN TECHNOLOGY, LTD. MEDICAL DEVICE WAS BEING USED. INVESTIGATION OF THIS EVENT IS CURRENTLY ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

COMPLAINANT REPORTED THAT A USER OF AN ITERO ELEMENT 2 SYSTEM EXPERIENCED A MINOR BURN ON HAND WHEN PLUGGING THE CABLE INTO AN OUTLET. THE USER REQUIRED GOING TO THE EMERGENCY ROOM TO ADDRESS THE REPORTED SYMPTOMS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.