MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-04-13 for 3M TRUE DEFINITION SCANNER WAND G6 75030 manufactured by 3m Espe Dental Products.
[5637017]
Dental office reported that three individuals experienced a shock when scanned using the 3m true definition scanner. One of these individuals was a dental assistant in the office who experienced moderate pain as a result. Information on the degree of pain or patient characteristics for the other two patients is not available to 3m espe dental. The office noted that the shocks occurred only in one operatory and did not occur in every scan. Upon investigation by 3m health care service personnel on (b)(6) 2015 a wiring problem was found in the 30+ year old dental chair (the chairman, model cm, li-32250) in the impacted operatory and intermittently, the faulty wiring was energizing the chair/patient. In these circumstances, the use of the true definition scanner in the patient's mouth allowed for a discharge of the energy to ground, resulting in the shock. The dentis has been advised of and agrees with the findings of the investigation that the chair was the cause of the shocks.
Patient Sequence No: 1, Text Type: D, B5
[13192091]
When manipulating the wiring of the chair, it was found that voltages measuring between 2 and 100 volts were present. None of the other dental chairs in the operatory had similar transient voltages. Appropriate electrical safety measures (isolation transformer) are present in the true definition scanner system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005174370-2015-00027 |
| MDR Report Key | 4687000 |
| Report Source | 05 |
| Date Received | 2015-04-13 |
| Date of Report | 2015-03-20 |
| Date of Event | 2015-03-13 |
| Date Mfgr Received | 2015-03-20 |
| Date Added to Maude | 2015-04-15 |
| 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 | 0 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 2510 CONWAY AVENUE |
| 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 TRUE DEFINITION SCANNER WAND |
| Generic Name | SYSTEM, OPTICAL IMPRESSION |
| Product Code | NOF |
| Date Received | 2015-04-13 |
| Model Number | G6 |
| Catalog Number | 75030 |
| Lot Number | G1449005 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-13 |