MAUDE MDR 4686997

MDR report key
4686997
Report number
3005174370-2015-00028
Event key
0
Event type
3
Date of event
2015-03-27
Date received
2015-04-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
2510 CONWAY AVENUE SAINT PAUL MN 55144 US
Phone
651-651-6517
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
13M TRUE DEFINITION SCANNER WANDSYSTEM, OPTICAL IMPRESSIONNOFG675030S1451028Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-04-1301. O

Event Narratives#

D

Patient 1

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.