MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-02-08 for 3M ESPE LAVA CHAIRSIDE ORAL SCANNER (COS) 68901 manufactured by 3m Espe Dental Products.
[3135811]
3m espe was informed that occasionally when scanning patients with the 3m espe lava chairside oral scanner (cos), the patient reports that the wand gave them a shock. No patient sought medical attention and no serious injury occurred as a result of the shock. This event, reported to 3m espe on (b)(6) 2012, was investigated by a trained service technician in (b)(6) 2012 and the lava cos unit was found to be performed as intended; it was determined that further investigation to understand the reported issue and make an informed reporting decision was necessary. Upon this investigation, it was determined that the outlet commonly used for the scanner was not properly grounded. Without proper ground, it is possible for patients to receive an electrical shock (leakage current to patient instead to ground) from use of this device. This leakage current is limited by the use of a medical grade power supply. Under multiple fault conditions (including loss of ground) the patient current could potentially exceed the limits of iec 60601-1, which led to this report. Since the scanner performed as intended, but inadequate ground wiring in the office resulted in patients receiving an electrical shock, this event is being reported.
Patient Sequence No: 1, Text Type: D, B5
[10458806]
On (b)(4) 2012, a representative of 3m visited the initial visit, the device checked out as performing as intended and it was determined that additional test equipment was needed in order to fully understand the cause of this complaint. On (b)(4) 2013, it was determined that the ground in the wall outlet commonly used for powering the scanner had no connection between the ground pin and the copper water pipe in office (copper water pipe running to ground). It was also found that the ground contact of that outlet was recessed to a point where it could not make contact with a ground pin on the power cord. The dentist was advised of these observations and was going to call in an electrician to check out the electrical wiring in the dental office and ensure that the outlets used for the scanner are properly grounded. 3m espe notes that the lava c. O. S. User manual informs the user that they must use a properly grounded outlet.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005174370-2013-00002 |
| MDR Report Key | 2961835 |
| Report Source | 05,07 |
| Date Received | 2013-02-08 |
| Date of Report | 2013-01-09 |
| Date Mfgr Received | 2013-01-09 |
| Device Manufacturer Date | 2010-01-01 |
| Date Added to Maude | 2013-02-28 |
| 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 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517331179 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M ESPE LAVA CHAIRSIDE ORAL SCANNER (COS) |
| Generic Name | OPTICAL IMPRESSION SYSTEM |
| Product Code | NOF |
| Date Received | 2013-02-08 |
| Catalog Number | 68901 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Address | SAINT PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-02-08 |