| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ELECTROTORQUE PLUS | ELECTRIC DENTAL HANDPIECE | KAVO DENTAL | EKK | 25LPA | 1002.1526 | NA | N | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2006-09-27 | 0 | 1. O |
Patient 1
A DENTIST REPORTED THAT A PATIENT RECEIVED A BURN TO THE SIDE OF HER TONGUE AND FLOOR OF HER MOUTH DURING THE USE OF A 25LPA HANDPIECE. THE PATIENT WAS PRESCRIBED DEXAMETHASONE RINSE AND IBUPROFEN. IT WAS REPORTED THAT THE PATIENT HAS SINCE 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 OF SERIAL NUMBER REVEALED THAT THE BEARINGS ARE WORN AND GRITTY IN THE DRIVE ASSEMBLY, SHAFT AND AXLE. THE TEETH ON THE SPUR WHEEL ARE BROKEN AND MISSING. A HIGH LEVEL OF DEBRIS WAS OBSERVED INSIDE THE HANDPIECE. VISUAL INSPECTION OF SERIAL NUMBER REVEALED THAT THE BEARINGS ARE WORN AND GRITTY IN THE DRIVE ASSEMBLY AND SHAFT. THE WATER PORT WAS OBSERVED TO BE CLOGGED. A HIGH LEVEL OF DEBRIS WAS ALSO OBSERVED INSIDE THE HANDPIECE. 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 HANDPIECES CAN POTENTIALLY GENERATE FRICTIONAL HEAT CAPABLE OF CAUSING SERIOUS BURN INJURIES TO THE PATIENT. IT ALSO STATES THAT THE HEAD OF THE ATTACHMENT SHOULD NOT BE USED AS A CHEEK OR TONGUE RETRACTOR.