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 2014-11-13 for PLASMABLADE PS300-002 4PK TNA manufactured by Medtronic Advanced Energy.
[5050519]
During a check of the system in biomed the unit failed the routine testing. There was high output on setting coag 5. The unit was tested three times, once with the plasmablade device and twice without. The unit was plugged into a power strip the first two times and a wall outlet the last time. There was no change in test results.
Patient Sequence No: 1, Text Type: D, B5
[12561753]
Product event (b)(4). Evaluation, result, conclusion: device discarded by user therefore analysis unable to be performed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103813596]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00110 |
| MDR Report Key | 4247521 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-11-13 |
| Date of Report | 2014-10-17 |
| Date of Event | 2014-10-17 |
| Date Mfgr Received | 2014-10-17 |
| Device Manufacturer Date | 2014-07-06 |
| Date Added to Maude | 2014-11-25 |
| 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 WHITNEY |
| 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 PS300-002 4PK TNA |
| Generic Name | ELECTROSURGICAL DEVICE |
| Product Code | DWG |
| Date Received | 2014-11-13 |
| Model Number | PS300-002 |
| Catalog Number | PS300-002 |
| Lot Number | 0007212025 |
| Device Expiration Date | 2017-07-06 |
| 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 |
| Manufacturer Address | 180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-13 |