3M TRUE DEFINITION SCANNER
Received Dec 21, 2016 · Event occurred Nov 14, 2016
Report 3005174370-2016-00154 · MDR key 6196478
Device
Generic name
System,optical Impression, Computer Assisted Design And Manufacturing (cad/cam)
Manufacturer
3m Espe Dental ProductsCatalog number
78052
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Code Available
- No Consequences Or Impact To Patient
- No Code Available
Narrative
Additional Manufacturer Narrative
AFTER THE TINGLING SENSATION WAS EXPERIENCED, THE TRUE DEFINITION SCANNER SYSTEM WAS UNPLUGGED FROM THE ELECTRICAL OUTLET AND THE SCAN WAS CONTINUED USING BATTERY POWER. NO SENSATION WAS EXPERIENCED DURING THE SCAN USING BATTERY POWER. 3M HAS REQUESTED THAT THE ENTIRE TRUE DEFINITION SCANNER UNIT BE RETURNED FOR TESTING TO ENSURE THE PRODUCT IS OPERATING IN SPECIFICATION. 3M IS STILL WAITING TO RECEIVE THIS UNIT BACK. IT IS ANTICIPATED THAT AN ELECTRICAL SITE ASSESSMENT WILL BE CONDUCTED AT THE UK DENTAL OFFICE. IF ANY FURTHER INFORMATION BECOMES AVAILABLE 3M WILL FILE A FOLLOW-UP REPORT.
Description of Event or Problem
ON (B)(6) 2016, 3M WAS NOTIFIED THAT A FEMALE SUBJECT EXPERIENCED AN ELECTRICAL SENSATION DURING A DEMONSTRATION SCANNING PROCEDURE USING THE 3M TRUE DEFINITION SCANNER. THE SUBJECT FELT A TINGLING SENSATION ON LOWER TOOTH #2 AND #3 AND SCANNING WAS IMMEDIATELY STOPPED. NO PATIENT INJURY OCCURRED.