MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-10-19 for 3M ESPE LAVA CHAIRSIDE ORAL SCANNER C.O.S. 68901 manufactured by 3m Espe Dental Products.
[2251275]
Dr (b)(6) dental office purchased a new lava chairside oral scanner (c. O. S. ). On (b)(6) 2011, introduction for theory and practice took place using an artificial model (phantom head). In addition, one dental assistant and two patients were part of the training (they were scanned using the lava c. O. S. ). There were no complaints on this day (b)(6) about a strange feeling during scanning. On the (b)(6) 2011, a patient reported that she felt a short tingle similar to a mild electrical shock. The treatment of the patient was stopped after the patient told the doctor about the sensation. Subsequently, (b)(6) one of the assistants also reported that she had a similar feeling the day before (b)(6). Both the patient and the assistant described the experience as a short tingle. Other symptoms or long-lasting effects have not been reported to 3m espe.
Patient Sequence No: 1, Text Type: D, B5
[9366560]
Results: the dentist's electrician was on site on (b)(6) 2011. The electrician used a special measuring instrument to check the whole electrical installation of the dental office. The measuring instrument showed that the protective earth (ground) connection from the power outlet was not working. The electrician found that the protective earth (grounding) contacts were out of order because they were painted with paint. All of the walls inside the dental office had been painted in 2011, during that time, the painter accidentally painted over the protective earth (ground) contacts in the wall outlets. The electrician used some sanding paper and cleaned these contacts. After he had done that, he measured again the complete installation and all values were within regulations. Conclusion: at this time 3m espe concludes that the mild electrical shock received was caused by a leakage current of the lava c. O. S. System, which normally would be dissipated by a correctly grounded outlet. The 3m espe continues to investigate this event and will provide supplemental follow-up reports, as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005174370-2011-00011 |
| MDR Report Key | 2304763 |
| Report Source | 05 |
| Date Received | 2011-10-19 |
| Date of Report | 2011-09-20 |
| Date of Event | 2011-09-19 |
| Date Mfgr Received | 2011-09-20 |
| Date Added to Maude | 2012-07-11 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANGIE DRAPER |
| Manufacturer Street | 3M CENTER BLDG. 275-2W-08 |
| Manufacturer City | SAINT PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517331179 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M ESPE LAVA CHAIRSIDE ORAL SCANNER C.O.S. |
| Generic Name | OPTICAL IMPRESSION SYSTEM |
| Product Code | NOF |
| Date Received | 2011-10-19 |
| Catalog Number | 68901 |
| ID Number | WAND: A10T1009 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Address | SAINT PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-10-19 |