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 2020-01-09 for MASTERMATIC LUX M25 L 1.009.3630 manufactured by Kavo Dental Gmbh.
[174312292]
The visual and functional inspection prior to the repair showed that the running characteristics of the handpiece have been out of specification. The bearings have been vibrating and grinding, the power consumption was far out of tolerance and the heat up was reproducible. After disassembling of the handpiece it got visible that the bearings have been worn out and that residue was inside the handpiece. This shows that the care and maintenance was not performed as requested by ifu. This led to stronger wear and higher friction and hence to 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 pushbutton 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. Exemption number e2010020. Kavo dental gmbh (b)(6) (the manufacturer) is submitting the report on behalf of kavo dental usa (the importer). [complaint #(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[174312293]
During a crown preparation to tooth #18 the handpiece heated up and burned the patient on left side of lip and inner cheek. Dentist prescribed peridex rinse and informed to rinse 2 times a day for a week and alternate doing salt water rinse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003637274-2020-00001 |
| MDR Report Key | 9568209 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-09 |
| Date of Report | 2020-01-09 |
| Date of Event | 2019-12-09 |
| Date Facility Aware | 2019-12-13 |
| Report Date | 2020-01-09 |
| Date Reported to FDA | 2020-01-09 |
| Date Reported to Mfgr | 2019-12-13 |
| Date Mfgr Received | 2019-12-13 |
| Device Manufacturer Date | 2017-05-02 |
| Date Added to Maude | 2020-01-09 |
| 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, 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 | MASTERMATIC LUX M25 L |
| Generic Name | DENTAL HANDPIECE |
| Product Code | EGS |
| Date Received | 2020-01-09 |
| Returned To Mfg | 2019-12-13 |
| Model Number | M25 L |
| Catalog Number | 1.009.3630 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 2 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 | 2020-01-09 |