3M TRUE DEFINITION SCANNER WAND

Additional Manufacturer Narrative

WHEN MANIPULATING THE WIRING OF THE CHAIR, IT WAS FOUND THAT VOLTAGES MEASURING BETWEEN 2 AND 100 VOLTS WERE PRESENT. NONE OF THE OTHER DENTAL CHAIRS IN THE OPERATORY HAD SIMILAR TRANSIENT VOLTAGES. APPROPRIATE ELECTRICAL SAFETY MEASURES (ISOLATION TRANSFORMER) ARE PRESENT IN THE TRUE DEFINITION SCANNER SYSTEM.

Description of Event or Problem

DENTAL OFFICE REPORTED THAT THREE INDIVIDUALS EXPERIENCED A SHOCK WHEN SCANNED USING THE 3M TRUE DEFINITION SCANNER. ONE OF THESE INDIVIDUALS WAS A DENTAL ASSISTANT IN THE OFFICE WHO EXPERIENCED MODERATE PAIN AS A RESULT. INFORMATION ON THE DEGREE OF PAIN OR PATIENT CHARACTERISTICS FOR THE OTHER TWO PATIENTS IS NOT AVAILABLE TO 3M ESPE DENTAL. THE OFFICE NOTED THAT THE SHOCKS OCCURRED ONLY IN ONE OPERATORY AND DID NOT OCCUR IN EVERY SCAN. UPON INVESTIGATION BY 3M HEALTH CARE SERVICE PERSONNEL ON (B)(6) 2015 A WIRING PROBLEM WAS FOUND IN THE 30+ YEAR OLD DENTAL CHAIR (THE CHAIRMAN, MODEL CM, LI-32250) IN THE IMPACTED OPERATORY AND INTERMITTENTLY, THE FAULTY WIRING WAS ENERGIZING THE CHAIR/PATIENT. IN THESE CIRCUMSTANCES, THE USE OF THE TRUE DEFINITION SCANNER IN THE PATIENT'S MOUTH ALLOWED FOR A DISCHARGE OF THE ENERGY TO GROUND, RESULTING IN THE SHOCK. THE DENTIS HAS BEEN ADVISED OF AND AGREES WITH THE FINDINGS OF THE INVESTIGATION THAT THE CHAIR WAS THE CAUSE OF THE SHOCKS.