MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-09-27 for ELECTROTORQUE PLUS 25LPA 1002.1526 manufactured by Kavo Dental.
[21255972]
A dentist reported that a patient received a burn to his cheek during the use of a 25lpa handpiece. The patient was prescribed kenalog in orabase to treat the patient's burn. It was reported that the patient has recovered.
Patient Sequence No: 1, Text Type: D, B5
[21345236]
The actual unit involved in the incident was returned for evaluation. It was observed that the had dents at the 1 and 9 o'clock positions on the water faceplate and at the 1 and 10 o'clock positions on the back end cap. It was observed that the head, insert, drive assembly and cover nut are all damaged due to the multiple dents in the head. The unit was disassemble for further inspection. It was observed that the bearings and shaft in the drive assembly are worn and gritty due to the multiple dents. A high amount of debris was also observed in 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 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419798-2006-00002 |
| MDR Report Key | 766022 |
| Report Source | 05,07 |
| Date Received | 2006-09-27 |
| Date of Report | 2006-08-28 |
| Date of Event | 2006-08-21 |
| Date Mfgr Received | 2006-08-28 |
| Device Manufacturer Date | 2004-07-01 |
| Date Added to Maude | 2006-10-03 |
| 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 | 2006-09-27 |
| Returned To Mfg | 2006-09-13 |
| Model Number | 25LPA |
| Catalog Number | 1002.1526 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 753882 |
| Manufacturer | KAVO DENTAL |
| Manufacturer Address | 340 E. MAIN ST. LAKE ZURICH IL 60047 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-09-27 |