MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-20 for 3M ESPE LAVA CHAIRSIDE ORAL SCANNER C.O.S. 68901 manufactured by 3m Espe Dental Products.
[17097319]
3m espe was notified on (b)(6) 2011, that one pt received a mild electrical shock when scanned with a 3m espe lava chairside oral scanner (c. O. S. ). The pt reported pain in the teeth for 2-3 hours following the shock. The pt did not seek additional medical attention and no serious injury occurred.
Patient Sequence No: 1, Text Type: D, B5
[17180545]
The dental office reported that three events occurred within a 2-day period using the same lava c. O. S. Device. Therefore, three reports are being submitted and this report is related to manufacturer report number 3005174370-2011-00003 and 3005174370-2011-00004. After equipment installation and initial training but before 3m completed its official certification training for the dentist, he used the lava c. O. S. To perform a scan of a pt during which time the first event occurred. During the scanning procedure, the dentist stated that he felt a palpable current when holding the tip of the wand on his palm. A mild shock occurred to the pt when the dentist touched the pts teeth with his finger; but the dentist did not feel the shock himself. : other: serial number (b)(4) refers to the unique serial number of the scanning wand component of the lava c. O. S. Device with a manufacture date of 04/2010. Additional method: an electrical safety check in the dental office revealed that there was a electrical potential between the neutral line and the protective earth on every power outlet the lava c. O. S. Device was connected to (ranging from 0. 9v to 18v) and the voltage was stable. Also, an initial check of the electrical safety of the device was checked in the office-the lava c. O. S. Device met its electrical safety specification. Subsequently, the lava c. O. S. Device was returned to 3m espe and was visually inspected and electrically tested. Visual inspection of the wand showed a small gap between the plastic housing and the metal tip of the wand. However, electrical testing confirmed the device met all electrical specifications. 3m espe reviewed the existing user manual; it instructs the user to examine the wand and the system (cart, screen, etc. ) for physical damage before each use and to contact customer support if there is visible damage. Conclusion: at this time 3m espe concludes that the lava c. O. S. Device itself did not cause the electrical shocks but acted as a conductor from a defective socket. 3m espe continues to investigate this event and will provide supplemental reports, as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005174370-2011-00002 |
| MDR Report Key | 2214094 |
| Report Source | 05,06 |
| Date Received | 2011-07-20 |
| Date of Report | 2011-06-21 |
| Date of Event | 2011-06-17 |
| Date Mfgr Received | 2011-06-21 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2012-06-20 |
| 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 |
| 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 | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| 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 C.O.S. |
| Generic Name | ORAL SCANNER |
| Product Code | NOF |
| Date Received | 2011-07-20 |
| Returned To Mfg | 2011-07-01 |
| Catalog Number | 68901 |
| ID Number | A10N1007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-07-20 |