MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-09-15 for PLASMABLADE PS300-002 4PK TNA manufactured by Medtronic Advanced Energy, Llc.
[14876599]
Around two minutes into a tonsilectomy and adenoidectomy procedure with use of the plasmablade tna device, the electrode wire fractured and detached from one side of the device housing. Another plasmablade tna device from the same lot was opened and utilized and the same issue occured. The customer opened a third plasmablade tna device from the same lot and the device was used successfully to complete the case. No patient impact reported.
Patient Sequence No: 1, Text Type: D, B5
[15473502]
Product event (b)(4). Method, results, conclusion: devices discarded therefore analysis unable to be performed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00087 |
| MDR Report Key | 4088155 |
| Report Source | 06,07 |
| Date Received | 2014-09-15 |
| Date of Report | 2014-08-19 |
| Date of Event | 2014-08-12 |
| Date Mfgr Received | 2014-08-19 |
| Device Manufacturer Date | 2014-02-17 |
| Date Added to Maude | 2014-09-26 |
| 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 | 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 PS300-002 4PK TNA |
| Generic Name | ELECTROSURGICAL DEVICE |
| Product Code | DWG |
| Date Received | 2014-09-15 |
| Model Number | PS300-002 |
| Catalog Number | PS300-002 |
| Lot Number | 0007021630 |
| Device Expiration Date | 2017-02-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2014-09-15 |