MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-10-30 for ARTAS FP-45616 manufactured by Restoration Robotics.
[4026904]
Discoloration observed on pins used in disposable skin tensioner. To date no serious injury has been reported.
Patient Sequence No: 1, Text Type: D, B5
[11415592]
Add'l model numbers: (b)(4). Discoloration due to insufficient cleaning of stainless steel pins during passivation process. There have been no adverse event associated with this issue. Users notification initiated 8 oct 2013. Correction 3006515340-10/17/13-001c, reported to (b)(4) field office (b)(4) 2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006515340-2013-00001 |
| MDR Report Key | 3472081 |
| Report Source | 05,06 |
| Date Received | 2013-10-30 |
| Date of Report | 2013-10-29 |
| Date of Event | 2013-10-08 |
| Date Added to Maude | 2013-12-23 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JIM TALBOT |
| Manufacturer Street | 128 BAYTECH DR |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal | 95134 |
| Manufacturer Phone | 4088836760 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 3006515340-10/17/13-001C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTAS |
| Generic Name | ARTAS SYSTEM |
| Product Code | ONA |
| Date Received | 2013-10-30 |
| Model Number | FP-45616 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESTORATION ROBOTICS |
| Manufacturer Address | SAN JOSE CA 95134 US 95134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-30 |