inforMED
InjuryNOF

3M TRUE DEFINITION SCANNER

Received Apr 24, 2017

Report 3005174370-2017-00036 · MDR key 6517540

Device

Generic name

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

Model number

G7

Catalog number

78052

Product problems

  • Appropriate Device Problem Term/Code Not Available
  • Appropriate Device Problem Term/Code Not Available

Patient

38 YR

  • No Consequences Or Impact To Patient
  • No Code Available
  • No Consequences Or Impact To Patient
  • No Code Available

Narrative

Additional Manufacturer Narrative

ELECTRICAL SAFETY TESTING ON THE 3M TRUE DEFINITION SCANNER, MOBILE EDITION WAS PERFORMED BY 3M ACCORDING TO ELECTRICAL SAFETY STANDARD IEC (B)(4). THE ANALYSIS FOUND THAT THE TRUE DEFINITION MOBILE UNIT IS OPERATING WITHIN SPECIFICATION. AN ELECTRICAL EVALUATION OF THE DENTAL OPERATORY WAS CONDUCTED AND ONE OF THE WALL OUTLETS IN THE OPERATORY WAS FOUND TO BE NOT PROPERLY GROUNDED, BUT DUE TO THE TYPE BF APPLIED PART THIS SHOULD HAVE MINIMAL EFFECT ON PATIENT LEAKAGE CURRENT GENERATED BY THE DEVICE. A NEARBY AIR CONDITIONER UNIT WAS BEING SERVICED AT THE TIME, AND THE TECHNICIAN PROPOSED THAT IT COULD HAVE INTERFERED WITH THE DEVICE. A MORE CONCLUSIVE ASSESSMENT OF THE SITE IS NEEDED TO ASSESS ANY IMPACTS FROM THE AIR CONDITIONER UNIT. THE INCIDENT OCCURRED DURING A DEMONSTRATION AND THE DEVICE IS NOT AT THE SITE.

Description of Event or Problem

ON (B)(6) 2017, 3M WAS NOTIFIED THAT A 3M SALES REPRESENTATIVE IN (B)(6) EXPERIENCED ELECTRICAL SENSATIONS DURING A SCANNING DEMONSTRATION USING THE 3M TRUE DEFINITION SCANNER, MOBILE EDITION. NO INJURY OCCURED AS A RESULT OF THIS EVENT.