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 INSTRUCTIONS FOR USE DOES CONTAIN THE 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.' ANY ADDITIONAL INFORMATION THAT BECOMES AVAILABLE WILL BE SUBMITTED AS A FOLLOW-UP REPORT.

Description of Event or Problem

THIS REPORT DETAILS AN EVENT IN WHICH A PATIENT IN FRANCE EXPERIENCED WHAT WAS REPORTED AS AN ELECTRIC TINGLE ON THE TEETH DURING USE OF THE 3M TRUE DEFINITION SCANNER IN (B)(6) 2015, A FEMALE PATIENT REPORTED AN ELECTRIC TINGLE ON THE TEETH DURING THE PASSAGE OF THE WAND. INVESTIGATION BY THE COMPUTER MANUFACTURER REVEALED THAT THE COMPUTER WAS NOT OPERATING PROPERLY; IT WAS RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION AND 3M WAS NOT APPRAISED OF THE FINDINGS.

Additional Manufacturer Narrative

A ENVIRONMENTAL ON-SITE ELECTRICAL ASSESSMENT WAS COMPLETED AT THE DENTAL OFFICE BY A 3M (B)(4) TECHNICIAN. IT WAS FOUND THAT THE DENTAL OFFICE CHAIRS WERE NOT GROUND CONNECTED AND ONE OF THOSE CHAIRS WAS ALSO NOT CORRECTLY ISOLATED. 3M INSTRUCTIONS FOR USE DO CONTAIN A WARNING TO "USE PROPERLY GROUNDED OUTLETS." IN ADDITION, 3M CENTER RECEIVED THE WAND (SERIAL NO. (B)(4)) BACK FROM THE DENTAL OFFICE FOR ENGINEERING ANALYSIS. SAFETY TESTING WAS PERFORMED AND THE WAND WAS FOUND TO BE WITHIN SAFETY LIMITS AND SPECIFICATION.