MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,company representative, report with the FDA on 2014-08-28 for PLASMABLADE 3.0 PS210-030S manufactured by Medtronic Advanced Energy, Llc.
[4862925]
Plasmablade device was being used on coag 6 and approximately 1 hour into a bilateral mastectomy case, it was noticed that the tip coating appeared to have melted. Another plasmablade device was opened and the case continued, but the second device had the same melting issue, which was discovered near the end of the case. Case was completed successfully with alternative medical device. The second device is being returned for investigation. The first device was discarded by the facility. This report represents product line #30-the device that was discarded.
Patient Sequence No: 1, Text Type: D, B5
[12181652]
Product event: (b)(4). Method, results: facility disposed of device. Device is not available for return and inspection. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103813132]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00077 |
| MDR Report Key | 4043711 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-08-28 |
| Date of Report | 2014-08-01 |
| Date of Event | 2014-07-29 |
| Date Mfgr Received | 2014-08-01 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2014-09-12 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | KAYLEE BOISVERT |
| Manufacturer Street | 180 INTERNATIONAL DRIVE |
| Manufacturer City | PORTSMOUTH NH 03801 |
| Manufacturer Country | US |
| Manufacturer Postal | 03801 |
| Manufacturer Phone | 6038426234 |
| Manufacturer G1 | MEDTRONIC ADVANCED ENERGY, LLC |
| Manufacturer Street | 180 INTERNATIONAL DRIVE |
| Manufacturer City | PORTSMOUTH NH 03801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLASMABLADE 3.0 |
| Generic Name | ELECTROSURGICAL DEVICE |
| Product Code | DWG |
| Date Received | 2014-08-28 |
| Model Number | PS210-030S |
| Catalog Number | PS210-030S |
| Lot Number | FL50805926 |
| Device Expiration Date | 2017-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC ADVANCED ENERGY, LLC |
| Manufacturer Address | 180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-28 |