inforMED
InjuryNOF

3M TRUE DEFINITION SCANNER WAND

Received Apr 13, 2015 · Event occurred Mar 27, 2015

Report 3005174370-2015-00028 · MDR key 4686997

Device

Generic name

System, Optical Impression

Model number

G6

Catalog number

75030

Lot number

S1451028

Product problems

  • Electrical Power Problem
  • Environmental Compatibility Problem

Patient

Not reported

  • Electric Shock

Narrative

Description of Event or Problem

DURING A SCANNING PROCEDURE USING A 3M TRUE DEFINITION SCANNER, A PATIENT EXPERIENCED A SHOCK INSIDE HER MOUTH AND ON HER ARM WHERE IT TOUCHED THE DENTAL CHAIR. THE INDIVIDUAL PERFORMING THE SCAN DID NOT FEEL A SHOCK. UPON INVESTIGATION, IT WAS LEARNED THAT THE TRUE DEFINITION SCANNER WAS PERFORMING AS INTENDED AND STRAY VOLTAGE WAS NOT IDENTIFIED. IT WAS DETERMINED THAT NOT ONLY WAS THE GROUND IN THE OUTLET INTO WHICH THE SCANNER HAD BEEN PLUGGED INTERMITTENTLY FAILING, BUT ALSO THAT THE 30+ YEAR OLD ELECTRIC DENTAL CHAIR WAS NOT PROPERLY GROUNDED. VOLTAGES ON THE CHAIR OF 112V WERE MEASURED. WHEN THE TRUE DEFINITION SCANNING WAND WAS PLACED INTO THE PATIENT'S MOUTH, IT ALLOWED FOR A DISCHARGE OF THE ENERGY TO GROUND, RESULTING IN THE SHOCK. THE DENTIST HAS BEEN ADVISED OF AND AGREES WITH THE FINDINGS OF THE INVESTIGATION THAT THE CHAIR WAS THE CAUSE OF THE SHOCKS.