MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-12 for GENTLEPOWER LUX CONTRA ANGLE 25LP 25 LP 1.001.2849 manufactured by Kavo Dental Gmbh.
[184984927]
Prior to the repair of the product an analysis has been performed. The instrument was in good condition from the outside. Already a short test run however showed, that the product ran outside of the specifications: loud, rough running noise, play in the guide bush and after a short test run (without load! ) the heat up was already reproducible. The current consumption was @ 500ma (vs. 150ma). After disassembling of the product heavy black residue got visible inside the head which indicates that the reprocessing and care is not performed as requested by ifu. The ball bearings in the head have been completely worn out and fell partially apart. In addition, the ball bearings of the intermediate drive and the intermediate piece ran rough and have been worn out. From technical aspect the root cause for the heating was therefore the strong residue in the instrument which led to increased friction and thus heating and also stronger wear and tear situation. The worn ball bearings also caused higher resistance and hence rise in temperature. The injury shows that the instrument has been used to keep the tongue away from treatment area. It is likely that this also caused an increase of the temperature as the push button could be pressed while the inner parts are rotating. This causes also high friction and a quick heat up. To avoid such issues the user instruction contains already several notes, warnings and requests how to prepare the handpiece for each treatment and how to use it: 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. The following guidelines must be observed to ensure save use of the electrically driven contra-angle handpieces: the service instructions for contra-angle handpieces must be precisely following when using kavo spray or quattrocare care systems. Before each use, the contra-angle handpiece must be checked for external damage. Before each use, perform a test run with the contra-angle handpiece, and watch for atypical heating and unusual noise and vibration. Immediately stop using contra-angle handpieces that act unusual. Never press the push button during operation. This also includes lifting the cheek or tongue! To ensure proper function, the medical device must be set up according to the reprocessing methods described in the kavo instructions for use, and the care products and care systems described therein must be used. Kavo recommends specifying a service interval at the dental office for a licensed shop to clean, service and check the functioning of the medical device. This service interval depends on the frequency of use and should be adjusted accordingly. Issue reported as similar products are sold to the us.
Patient Sequence No: 1, Text Type: N, H10
[184984928]
During a dental treatment the handpiece heated up and burned the patient badly on tongue. As patient was numb, she did not feel the burn. Also, the dentist did not recognize the heat up as only the head got hot not the shaft. The burn had to be treated by dentist and a specialist. Nevertheless, the tongue did not heal fully. There is still tissue missing and an area is still numb. The patient is still under treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003637274-2020-00006 |
| MDR Report Key | 9823236 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2014-07-07 |
| Date Added to Maude | 2020-03-12 |
| 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 | 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 | GENTLEPOWER LUX CONTRA ANGLE 25LP |
| Generic Name | DENTAL HANDPIECE |
| Product Code | EGS |
| Date Received | 2020-03-12 |
| Returned To Mfg | 2020-03-02 |
| Model Number | 25 LP |
| Catalog Number | 1.001.2849 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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. Deathisabilit | 2020-03-12 |