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 2014-12-12 for PLASMABLADE 3.0 PS210-030S manufactured by Medtronic Advanced Energy, Llc.
[5213287]
A few minutes into the case, after the customer stopped depressing the coag button, the generator still showed as active and still gave the coag tone, however, the hand piece wasn? T active (there was no rf energy going to the hand piece). The generator was restarted and the issue was resolved. Approximately 10 minutes later, while being used on coag, the generator stopped showing as active, there was no activation tone and the screen did not indicated coag as active. This occurred although the customer was continuing to depress the coag button on the hand piece and the hand piece itself was still coagulating and still had rf energy going to it. The issue was resolved when the customer stopped depressing coag on the hand piece. Approximately 15 minutes later, after a subsequent activation on coag, when the customer stopped depressing the coag button, the generator still showed as active and still gave the coag tone, however, the hand piece wasn? T active and there was no rf energy going to the hand piece. A different generator was brought in and used with the same hand piece to successfully complete the case. Cut was not affected.
Patient Sequence No: 1, Text Type: D, B5
[12665220]
(b)(4). Method, 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
[103814621]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00120 |
| MDR Report Key | 4325929 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-12-12 |
| Date of Report | 2014-11-14 |
| Date of Event | 2014-11-14 |
| Date Mfgr Received | 2014-11-14 |
| Date Added to Maude | 2014-12-29 |
| 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 | 2014-12-12 |
| Model Number | PS210-030S |
| Catalog Number | PS210-030S |
| Lot Number | UNKNOWN |
| 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 | 2014-12-12 |