inforMED
MalfunctionNOF

3M TRUE DEFINITION SCANNER

Received Jul 1, 2016

Report 3005174370-2016-00069 · MDR key 5766699

Device

Generic name

System,optical Impression, Computer Assisted Design And Manufacturing (cad/cam)

Catalog number

75030

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

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.'

Description of Event or Problem

THIS REPORT DETAILS AN EVENT IN WHICH A DENTAL PROFESSIONAL IN (B)(6) EXPERIENCED WHAT WAS REPORTED AS AN ELECTRIC PULSE ON THE TEETH DURING USE OF THE 3M TRUE DEFINITION SCANNER. THE REPORT OF ELECTRIC PULSE OCCURRED IN (B)(6) 2015 WHEN THE DENTAL PROFESSIONAL USED THE WAND ON HERSELF WHILE CONDUCTING A TRAINING SESSION. THIS EVENT WAS INVESTIGATED AND THE TRUE DEFINITION SCANNING SYSTEM AND ELECTRICAL GROUNDING WITHIN THE DENTAL OFFICE WERE FOUND TO BE OPERATING CORRECTLY; NO FURTHER ACTION WAS TAKEN AT THAT TIME. SUBSEQUENT USE OF THE SCANNING SYSTEM BETWEEN (B)(6) 2015 RESULTED IN NO COMPLAINTS FROM ANY PATIENTS.

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 SPECIFICATIONS.