3M TRUE DEFINITION SCANNER
Received Feb 20, 2017
Report 3005174370-2017-00009 · MDR key 6343231
Device
Generic name
System,optical Impression, Computer Assisted Design And Manufacturing (cad/cam)
Manufacturer
3m Espe Dental ProductsCatalog number
78052
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
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
A SERVICE TECHNICIAN COMPLETED AN ELECTRICAL ASSESSMENT AT THE REPORTING OFFICE ON 01/19/2017. IT WAS NOTED THAT THE ACTING CLINICIAN SCANNED THE SUBJECT USING THE 3M TRUE DEFINITION SCANNER, MOBILE EDITION WHILE ON BATTERY POWER. IT WAS ALSO NOTED THAT THE SUBJECT IS VERY SENSITIVE AND MAY HAVE BROKEN FRONT TEETH AND MINOR ENAMEL THICKNESS PROBLEMS. ELECTRICAL SAFETY TESTING ON THE 3M TRUE DEFINITION SCANNER, MOBILE EDITION WAS PERFORMED BY THE SERVICE TECHNICIAN ACCORDING TO ELECTRICAL SAFETY STANDARD VDE0751 (IEC62353). THE DEVICE MET ALL SPECIFICATIONS WHEN USED WITH THE PROVIDED ISOLATION TRANSFORMER AND POWER SUPPLY.
Description of Event or Problem
ON (B)(6) 2017, 3M WAS NOTIFIED THAT TWO DENTAL EMPLOYEES EXPERIENCED SOMETHING LIKE AN ELECTRICAL IMPULSE DURING SCANNING ON THE FRONT TEETH USING THE 3M TRUE DEFINITION SCANNER, MOBILE EDITION. THIS REPORT IS BEING SUBMITTED FOR THE SECOND EMPLOYEE. NO INJURY OCCURED AS A RESULT OF THIS EVENT.