3M TRUE DEFINITION SCANNER
Received Dec 21, 2016 · Event occurred Nov 14, 2016
Report 3005174370-2016-00153 · MDR key 6196476
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
THE TRUE DEFINITION SCANNER SYSTEM INVOLVED IN THIS EVENT WAS SITTING ON THE WORK SURFACE CHARGING IN AN OUTLET WITHOUT USING AN ISOLATION TRANSFORMER (ISO PUCK). THE IFU STATES THAT "A QUALIFIED (UL LISTED) STAND-ALONE ISOLATION TRANSFORMER IS PROVIDED TOGETHER WITH A SMALL POWER SUPPLY COMPONENT FOR THE TABLE COMPUTER. THESE MUST BE USED TOGETHER. THE 3M¿ TRUE DEFINITION SCANNER, MOBILE EDITION IS INTENDED TO OPERATE ROUTINELY WHILE CONNECTED TO POWER. USERS MAY ELECT TO EQUIP MULTIPLE LOCATIONS WITH THE 3M SUPPLIED OR RECOMMENDED ISOLATION TRANSFORMER AND POWER SUPPLY COMPONENT TO SIMPLIFY TRANSPORT. IN THIS CASE, IT IS EXPECTED THESE PARTS ARE INCORPORATED INTO THE OPERATORIES IN A SEMI-PERMANENT FASHION." 3M HAS REQUESTED THAT THE ENTIRE TRUE DEFINITION UNIT BE RETURNED TO 3M 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 MALE SUBJECT EXPERIENCED AN ELECTRICAL SENSATION DURING A DEMONSTRATION SCANNING PROCEDURE USING THE 3M TRUE DEFINITION SCANNER. THE SUBJECT FELT TINGLING SENSATION ON LOWER TOOTH #2 AND #3. SCANNING WAS IMMEDIATELY STOPPED. NO PATIENT INJURY OCCURRED.