3M TRUE DEFINITION SCANNER

Additional Manufacturer Narrative

APPROPRIATE ELECTRICAL SAFETY MEASURES (ISOLATION TRANSFORMER) ARE PRESENT IN THE TRUE DEFINITION SCANNER SYSTEM. THE 3M TRUE DEFINITION SCANNER USER MANUAL AND INSTRUCTIONS FOR USE (IFU) (AVAILABLE IN ENGLISH AND ITALIAN) CONTAIN THE FOLLOWING: "WARNING. TO REDUCE THE RISKS ASSOCIATED WITH HAZARDOUS VOLTAGE AND FIRE - USE ONLY A PROPERLY GROUNDED POWER OUTLET; DO NOT USE EXTENSION CORDS OR MULTIPLE PORTABLE POWER SOCKET OUTLETS.' A THIRD PARTY SITE ASSESSMENT IS PLANNED TO TAKE PLACE AFTER THE (B)(6) HOLIDAY ((B)(6) 2016). 3M MAY ALSO BE PROVIDED WITH A COPY OF THE LATEST YEARLY POWER SOCKET ASSESSMENT. ANY ADDITIONAL INFORMATION THAT BECOMES AVAILABLE WILL BE SUBMITTED BY 3M IN A FOLLOW-UP REPORT.

Description of Event or Problem

ON (B)(6) 2016, 3M LEARNED THAT DURING THE USE OF A 3M TRUE DEFINITION SCANNER, AN (B)(6) YEAR-OLD FEMALE PATIENT EXPERIENCED AN ELECTRICAL SENSATION/SHOCK WHEN THE SCANNING WAND TOUCHED HER TEETH. THIS EVENT OCCURRED IN ITALY AND DURING THE SCAN IN WHICH THE ELECTRICAL SENSATION/SHOCK OCCURRED, THE DENTIST REPORTED THAT THE TRUE DEFINITION SCANNER WAS PLUGGED INTO AN EXTENSION CORD.

Additional Manufacturer Narrative

(B)(4) RECEIVED AN ELECTRICAL SAFETY INSPECTION REPORT FROM THE DENTIST WHICH STATED THAT THE DENTAL CHAIR WAS FOUND TO HAVE NO FUNCTIONAL DEFECTS OR DEFICIENCIES THAT WERE SAFETY-RELATED. NO FURTHER COMPLAINTS HAVE BEEN REPORTED BY THE DENTAL OFFICE SINCE THEY DISCONTINUED USE OF THE EXTENSION CORD WITH THE TRUE DEFINITION SCANNER.