MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-02-20 for 3M TRUE DEFINITION SCANNER 78052 manufactured by 3m Espe Dental Products.
[67802801]
A service technician completed an electrical assessment at the reporting office on 01/19/17. The analysis found that the system was in operation without the factory supplied isolation transformer and power supply. In addition, the device was used with a 2-pin power cable instead of a iec certified approved power supply cord. It was also noted that the subject is very sensitive and may have broken front teeth and minor enamel thickness problems. Appropriate electrical safety measures (isolation transformer) are present in the true definition scanner, mobile edition. The instructions for use contains the warnings: 'to reduce the risks associated with hazardous voltage and fire - use only a properly grounded power outlet; do not use extension cords or multiple portable power socket outlets, and " use the isolation transformer and power adapter provided by 3m to power and recharge the tablet. " electrical safety testing on the 3m true definition scanner, mobile edition was performed by the service technician according to electrical safety standard vde0751 ((b)(4)). The device met all specifications when used with the provided isolation transformer and power supply.
Patient Sequence No: 1, Text Type: N, H10
[67802802]
On (b)(6) 2017, 3m was notified that two dental employees experienced something like an electrical impulse during scanning of the front teeth using the 3m true definition scanner, mobile edition. This report is being submitted for the first employee. No injury occured as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2017-00008 |
| MDR Report Key | 6343225 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-02-20 |
| Date of Report | 2017-01-18 |
| Date Mfgr Received | 2017-01-18 |
| Date Added to Maude | 2017-02-20 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANGIE DRAPER |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517331179 |
| Manufacturer G1 | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 551441000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M TRUE DEFINITION SCANNER |
| Generic Name | SYSTEM,OPTICAL IMPRESSION, COMPUTER ASSISTED DESIGN AND MANUFACTURING (CAD/CAM) |
| Product Code | NOF |
| Date Received | 2017-02-20 |
| Catalog Number | 78052 |
| Operator | DENTIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Address | 2510 CONWAY AVENUE ST. PAUL MN 551441000 US 551441000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-20 |