MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-09 for KAVO DIAGNODENT 2095 0.574.0500 manufactured by Kavo Dental Gmbh.
[62383220]
The product was not available for the manufacturer for analysis, but a representative of the local dealer visited the customer to check the root cause. It turned out quickly that the snap-on mounting of the light probe was worn out. It was verified by comparing the retention force between a new light probe (which was good) and the used one. It turned out that the customer did not follow the sterilization process as described in the instruction for use and also not the instruction how to prepare the product for use. Hence customer got not aware that the light probe was not correctly in place. To avoid such incidents the instruction for use contains already the necessary instructions how to maintain and use the product: operation / handling: select light probe a or b and place on handpiece. Make sure the probe is properly seated. Setup methods according to din en iso 17664. Restriction on reuse: the probes can be sterilised more than 500 times when handled properly. The probes are subject to wear. Sterilisation: only the grip sleeves and probes can be sterilised up to 138? C. The probes can be sterilised in the probe holder in the steribox.. Insert the probes in the probe holder in the steribox in the right probe storage space. Product not supplied by owner.
Patient Sequence No: 1, Text Type: N, H10
[62383221]
It was reported that during a dental medical examination the light probe detached from the grip sleeve, fell into patients mouth and was swallowed by patient ((b)(6) infant). Two days later the probe was defecated on the natural way without causing any trouble. No medical care was necessary. The incident occured more than one year ago and further details are not available. Hence the 'date of event' is best estimate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003637274-2016-00074 |
| MDR Report Key | 6157469 |
| Date Received | 2016-12-09 |
| Date of Report | 2016-11-30 |
| Date of Event | 2015-10-16 |
| Date Mfgr Received | 2016-11-30 |
| Device Manufacturer Date | 2000-06-29 |
| Date Added to Maude | 2016-12-09 |
| 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, BW 88400 |
| Manufacturer Country | GM |
| Manufacturer Postal | 88400 |
| Manufacturer Phone | 735156 |
| Manufacturer G1 | KAVO DENTAL GMBH |
| Manufacturer Street | BISMARCKRING 39 |
| Manufacturer City | BIBERACH / RISS, BW 88400 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 88400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | KAVO DIAGNODENT 2095 |
| Generic Name | CARIES DETECTOR |
| Product Code | NBL |
| Date Received | 2016-12-09 |
| Model Number | 2095 |
| Catalog Number | 0.574.0500 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KAVO DENTAL GMBH |
| Manufacturer Address | BISMARCKRING 39 BIBERACH / RISS, BW 88400 GM 88400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-09 |