| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ELECTROTORQUE PLUS | ELECTRIC DENTAL HANDPIECE | KAVO AMERICA | EKK | 25LHA | 0553.5350 | NA | K934783 | N | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2006-10-26 | 0 | 1. O |
Patient 1
A DENTIST REPORTED THAT A PATIENT RECEIVED A BURN ON THE INSIDE OF HER CHEEK NEAR TOOTH NUMBER 18, DURING THE USE OF A 25LHA HANDPIECE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS, "CANALOGAN" IN ORALBASE AND PROVIDED WITH A DEXAMETHASONE ORAL RINSE. IT WAS REPORTED THAT THE PT RETURNED TO THE DENTAL OFFICE IN 2006, FOR FOLLOW UP AND THE PATIENT HAD RECOVERED.
Patient 1
TWO HAND PIECES WERE RECEIVED FROM THE DENTAL OFFICE. IT WAS REPORTED BY THE DENTAL OFFICE THAT IT IS UNCERTAIN WHICH HANDPIECE WAS ASSOCIATED WITH THE INCIDENT. VISUAL INSPECTION REVEALED THAT BEARINGS WERE WORN AND GRITTY IN THE DRIVE ASSEMBLY AND SHAFT. THE WATER PORTS WERE OBSERVED TO BE CLOGGED AND THE CHUCK WAS NOTED TO SLIP. A MODERATE LEVEL OF DEBRIS WAS OBSERVED INSIDE THE HANDPIECE. VISUAL INSPECTION REVEALED THAT THE BEARINGS WERE WORN AND GRITTY IN THE DRIVE ASSEMBLY. THE WATER PORTS WERE OBSERVED TO BE CLOGGED. A HIGH LEVEL OF DEBRIS WAS OBSERVED INSIDE THE HANDPIECE. DURING A FOLLOW UP CALL WITH THE DENTAL OFFICE BY THE MANUFACTURER, IT WAS REPORTED THAT THE HANDPIECE MAY NOT HAVE BEEN MAINTAINED ACCORDING TO THE MANUFACTURER'S RECOMMENDATIONS. IT WAS REPORTED THAT THE HANDPIECE IS NOT CLEARED OF DEBRIS UNTIL AFTER THE UNIT HAS BEEN REMOVED FROM THE AUTOCLAVE. THE DENTAL OFFICE WAS ADVISED THAT PERFORMING THIS PRACTICE MAY CAUSE THE DEBRIS TO BECOME BAKED INSIDE THE HANDPIECE. THE OFFICE WAS REEDUCATED AS TO THE PROPER MAINTENANCE OF THE HANDPIECE AND WAS PROVIDED WITH MAINTENANCE INSTRUCTIONS. A CAUTIONARY STATEMENT IS INCLUDED WITH EACH UNIT WHICH STATES THAT ELECTRIC MICROMOTORS GENERATE SIGNIFICANTLY MORE POWER THAN TRADITIONAL AIR TURBINES AND AIR MOTORS. DUE TO INCREASED TORQUE AND SPEED, POORLY MAINTAINED, DAMAGED OR MISUSED HANDPIECE CAN POTENTIALLY GENERATE FRICTIONAL HEAT CAPABLE OF CAUSING SERIOUS BURN INJURIES TO THE PATIENT. IT ALSO STATES THAT PRESSURE SHOULD NOT BE APPLIED TO THE CHUCK RELEASE BUTTON WHILE THE HANDPIECE IS ROTATING; THIS INCLUDES USING THE HEAD OF THE ATTACHMENT AS A CHEEK OR TONGUE RETRACTOR.