3M TRUE DEFINITION SCANNER
Received Oct 19, 2016 · Event occurred Sep 20, 2016
Report 3005174370-2016-00113 · MDR key 6042702
Device
Generic name
System,optical Impression, Computer Assisted Design And Manufacturing (cad/cam)
Manufacturer
3m Espe Dental ProductsCatalog number
78007
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
AN IN OFFICE ELECTRICAL EVALUATION WAS CONDUCTED AND FOUND THAT THE OUTLET IN THE DENTAL OFFICE WAS NON-CONFORMING, AS IT WAS NOT APPROPRIATELY GROUNDED FOR THE CONNECTION TO THE 3M TRUE DEFINITION SCANNER. APPROPRIATE ELECTRICAL SAFETY MEASURES (ISOLATION TRANSFORMER) ARE PROVIDED WITH 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.
Description of Event or Problem
ON (B)(6) 2016, IT WAS REPORTED THAT A FEMALE PATIENT IN (B)(6) EXPERIENCED AN ELECTRICAL IMPULSE DURING USE OF THE 3M TRUE DEFINITION SCANNER.