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 2014-10-09 for PLASMABLADE 3.0S PS210-030S manufactured by Medtronic Advanced Energy, Llc.
[19591620]
Case #1 surgeon reports reversed activation on the pulsar i generator. When cut is pressed, display screen on generator show that coag mode is active. When coag is pressed, display screen on generator show that cut mode is active. Surgeon completed the case by pressing opposite button on hand piece to achieve desired effect. Patient information is unavailable as facility staff does not recall which case the issue occurred in. The surgeon using the generator is a new user of the product. Sales representative clarified that this may have been a customer confusion issue.
Patient Sequence No: 1, Text Type: D, B5
[19914877]
(b)(4). Method: facility disposed of device. Device is not available for return and inspection. Results: facility disposed of device. Device is not available for return and inspection. Product event: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103813384]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00098 |
| MDR Report Key | 4154807 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-10-09 |
| Date of Report | 2014-09-11 |
| Date of Event | 2014-09-10 |
| Date Mfgr Received | 2014-09-11 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2014-10-22 |
| 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 3.0S |
| Generic Name | ELECTROSURGICAL DEVICE |
| Product Code | DWG |
| Date Received | 2014-10-09 |
| Model Number | PS210-030S |
| Catalog Number | PS210-030S |
| Lot Number | FL50801721 |
| Device Expiration Date | 2017-03-01 |
| 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 | 2014-10-09 |