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 2016-12-21 for 3M TRUE DEFINITION SCANNER 78052 manufactured by 3m Espe Dental Products.
[63052338]
The true definition scanner system involved in this event was sitting on the work surface charging in an outlet without using an isolation transformer (iso puck). The ifu states that "a qualified (ul listed) stand-alone isolation transformer is provided together with a small power supply component for the table computer. These must be used together. The 3m? True definition scanner, mobile edition is intended to operate routinely while connected to power. Users may elect to equip multiple locations with the 3m supplied or recommended isolation transformer and power supply component to simplify transport. In this case, it is expected these parts are incorporated into the operatories in a semi-permanent fashion. " 3m has requested that the entire true definition unit be returned to 3m for testing to ensure the product is operating in specification. 3m is still waiting to receive this unit back. It is anticipated that an electrical site assessment will be conducted at the uk dental office. If any further information becomes available 3m will file a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[63052339]
On (b)(6) 2016, 3m was notified that a male subject experienced an electrical sensation during a demonstration scanning procedure using the 3m true definition scanner. The subject felt tingling sensation on lower tooth #2 and #3. Scanning was immediately stopped. No patient injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2016-00153 |
| MDR Report Key | 6196476 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-12-21 |
| Date of Report | 2016-11-23 |
| Date of Event | 2016-11-14 |
| Date Mfgr Received | 2016-11-23 |
| Date Added to Maude | 2016-12-21 |
| 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 | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| 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 | 2016-12-21 |
| Catalog Number | 78052 |
| Operator | SERVICE PERSONNEL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-12-21 |