MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-10-26 for ELECTROTORQUE PLUS 25LHA 0553.5350 manufactured by Kavo America.
[522490]
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 Sequence No: 1, Text Type: D, B5
[7913779]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419798-2006-00006 |
| MDR Report Key | 774627 |
| Report Source | 05 |
| Date Received | 2006-10-26 |
| Date of Report | 2006-09-27 |
| Date of Event | 2006-08-10 |
| Date Mfgr Received | 2006-09-27 |
| Date Added to Maude | 2006-11-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOHN MILLER, DIR |
| Manufacturer Street | 901 WEST OAKTON STREET |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 8473643931 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECTROTORQUE PLUS |
| Generic Name | ELECTRIC DENTAL HANDPIECE |
| Product Code | EKK |
| Date Received | 2006-10-26 |
| Returned To Mfg | 2006-09-13 |
| Model Number | 25LHA |
| Catalog Number | 0553.5350 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 762409 |
| Manufacturer | KAVO AMERICA |
| Manufacturer Address | 340 EAST MAIN ST. LAKE ZURICH IL 60047 US |
| Baseline Brand Name | ELECTROTORQUE PLUS |
| Baseline Generic Name | ELECTRIC DENTAL HANDPIECE |
| Baseline Model No | 25LHA |
| Baseline Catalog No | 0553.5350 |
| Baseline ID | NA |
| Baseline Device Family | ELECTROTORQUE PLUS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K934783 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-10-26 |