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 2014-09-04 for PLASMABLADE PS300-002 4PK TNA manufactured by Medtronic Advanced Energy (salient).
[15911587]
After 5 minutes of use the surgeon saw a glow at the device tip and felt as though the device was arcing. The surgeon ceased activation, inspected the device, and noticed that the electrode wire was detached on one side of the tip housing (still attached on the other side. ) surgeon changed the device tip and completed the case without further incident. There was no patient impact or injury.
Patient Sequence No: 1, Text Type: D, B5
[16065074]
(b)(4). Method, results, conclusion: product received by manufacturer and pending inspection. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[37632192]
(b)(4). Testing performed: device packaging inspection: received in fedex small pak. Received in single biohazard bag. No original packaging included, device information was confirmed via eeprom verification reader. Lot number of device returned matches the lot number of complaint device and it is therefore believed that the returned device is the complaint device. No additional paperwork included. Device visual inspection: handpiece and adenoid tip returned. All devices appear used as indicated by blood splatter and charring. Buttons have a definitive tactile feel. All components appear intact and in place. Adenoid tip wire is broken. Functional inspection: functional inspection not required. Lhr review: lhr 0007186683 was reviewed and no similar failures were noted in the record. Investigation conclusion: the complaint is confirmed as the adenoid tip wire is fractured on the returned device. This complaint has been seen in the past and been addressed through a situation analysis (b)(4). A capa (b)(4) is currently open as well to address this issue. The complaint will continue to be monitored through gch. Reference documents: (b)(4) product and specification plan - plasmablade tna product family (b)(4) complaint investigation work instruction (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[37632193]
After 5 minutes of use the surgeon saw a glow at the device tip and felt as though the device was arcing. The surgeon ceased activation, inspected the device, and noticed that the electrode wire was detached on one side of the tip housing (still attached on the other side. ) surgeon changed the device tip and completed the case without further incident. There was no patient impact or injury.
Patient Sequence No: 1, Text Type: D, B5
[103813300]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00081 |
| MDR Report Key | 4061710 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-09-04 |
| Date of Report | 2014-10-24 |
| Date of Event | 2014-08-06 |
| Date Mfgr Received | 2014-10-24 |
| Device Manufacturer Date | 2014-06-23 |
| Date Added to Maude | 2014-09-18 |
| 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 PS300-002 4PK TNA |
| Generic Name | ELECTROSURGICAL DEVICE |
| Product Code | DWG |
| Date Received | 2014-09-04 |
| Returned To Mfg | 2014-08-26 |
| Model Number | PS300-002 |
| Catalog Number | PS300-002 |
| Lot Number | 0007186683 |
| Device Expiration Date | 2017-06-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC ADVANCED ENERGY (SALIENT) |
| Manufacturer Address | 180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-04 |