MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-07 for COMFORTDRIVE 200XDR 1.007.3570 manufactured by Kavo Dental Gmbh.
[178208289]
During the analysis of the product it was found that the head had a dent. This caused the back cap to stick in after inserting the bur. The result was unusual inner friction and hence the heat up of the head. The dent shows that the handpiece received a strong hit, e. G. A drop during reprocessing. The ifu contains several notes and warnings to avoid that handpieces which are running out of specification get used for treatments: warning hazards for the care provider and the patient. In the case of damage, irregular running noise, excessive vibration, untypical warming or when the cutter or grinder cannot be held. Do not use further and notify service. Caution burning hazard from hot instrument head or hot instruments cover. If the instrument overheats, burns may arise in the oral area. Never contact soft tissue with the instrument head or instrument cover. Caution hazard from the use of handpieces equipped with electronic micromotors. Electronic micromotors generate much more energy than conventional pneumatic turbines and motors. Given the higher torque and speed, handpieces that are poorly serviced, damaged or used improperly can overheat which can cause serious burn injuries to the patient. Observe the following points. The following guidelines must be observed to ensure save use of the electrically driven handpieces: the service instructions for handpieces must be precisely following when using kavo spray or quattrocare care systems. Before each use, the handpiece must be checked for external damage. Before each use, perform a test run with the handpiece, and watch for atypical heating and unusual noise and vibration. Immediately stop using handpieces that act unusual. Never press the push button during operation. This also includes lifting the cheek or tongue! We recommend returning the handpieces to kavo at regular intervals for testing, setup and servicing. The frequency of the care depends on the instruments use. The contra-angle handpieces must be setup according to the kavo instructions to ensure proper functioning. Exemption number e2010020. Kavo dental gmbh germany (the manufacturer) is submitting the report on behalf of kavo dental usa (the importer). [(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[178208290]
During a standard dental treatment the handpiece heated up and caused a burn on the patients tongue with the size of a quarter. Doctor decided to perform a diode laser treatment to help healing. Patient was prescribed ao provantage antioxidant gel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003637274-2015-00002 |
| MDR Report Key | 9680462 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-07 |
| Date of Report | 2015-04-02 |
| Date of Event | 2015-03-11 |
| Date Facility Aware | 2015-03-11 |
| Report Date | 2015-04-02 |
| Date Reported to FDA | 2015-04-02 |
| Date Reported to Mfgr | 2015-03-11 |
| Date Mfgr Received | 2015-03-11 |
| Device Manufacturer Date | 2010-06-24 |
| Date Added to Maude | 2020-02-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KLAUS REISENAUER |
| Manufacturer Street | BISMARCKRING 39 |
| Manufacturer City | BIBERACH / RISS, BW 88400 |
| Manufacturer Country | GM |
| Manufacturer Postal | 88400 |
| Manufacturer G1 | KAVO DENTAL GMBH |
| Manufacturer Street | BISMARCKRING 39 |
| Manufacturer City | BIBERACH / RISS, 88400 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 88400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMFORTDRIVE 200XDR |
| Generic Name | DENTAL HANDPIECE |
| Product Code | EKX |
| Date Received | 2020-02-07 |
| Returned To Mfg | 2015-03-16 |
| Model Number | 200XDR |
| Catalog Number | 1.007.3570 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KAVO DENTAL GMBH |
| Manufacturer Address | BISMARCKRING 39 BIBERACH / RISS, 88400 GM 88400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-07 |