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 2014-12-18 for PLASMABLADE TNA PS300-002 manufactured by Medtronic Advanced Energy, Llc.
[5142552]
During use in a tonsilectomy and adenoidectomy case the housing on two plasmablade tna devices melted. There was no patient impact and the customer continued the procedure with the device.
Patient Sequence No: 1, Text Type: D, B5
[12738031]
Method: product scheduled for return but not received by manufacturer for inspection. Eval results: product scheduled for return but not received by manufacturer for inspection. Eval code conclusion: product scheduled for return but not received by manufacturer for inspection. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[38658641]
(b)(4) investigation plan: visual inspection functional inspection (if applicable) lhr review complaint device details: device name: plasmablade ps300-002 4pk tna product number: ps300-002 lot number: 0007269514 expiration date: 2017-09-03 quantity returned: 2 testing performed: device packaging inspection: both devices were received in a corrugated cardboard box, wrapped in bubble wrap. The devices were contained within a tna packaging tray that had the label taped to the top to prevent the devices from falling out. No biohazard bags were utilized. Tyvek lid returned with product shows ps300-002, lot 0007269514, exp. 2017/09 which matches the information in (b)(4). There are no discrepancies between what is listed in (b)(4) and what was returned. No additional documents were included in the return. Device visual inspection: device 1: device has evidence of use (charring, blood splatter) all components appear intact with the exception of the housing, which has evidence of melting at corners. Visual signs of melting match the description in (b)(4). Device 2: device has evidence of use (charring, blood splatter) all components appear intact with the exception of the housing, which has evidence of melting at corners. Visual signs of melting match the description in (b)(4). Functional inspection: functional inspection was not performed as the complaint was confirmed via visual inspection. Lhr review: lhr 0007269514 was reviewed and no discrepancies were found that would indicate the occurrence of this failure mode within the lot. Investigation conclusion: the complaint is confirmed as the adenoid tip housing is melted on the returned devices. This complaint has been seen in the past and been addressed through (b)(4). A capa ((b)(4)) is currently open as well to address this issue. The complaint will continue to be monitored through (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[38658642]
During use in a tonsilectomy and adenoidectomy case the housing on two plasmablade tna devices melted. There was no patient impact and the customer continued the procedure with the device.
Patient Sequence No: 1, Text Type: D, B5
[103814385]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00125 |
| MDR Report Key | 4339552 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-12-18 |
| Date of Report | 2014-11-19 |
| Date of Event | 2014-11-19 |
| Date Mfgr Received | 2014-11-19 |
| Date Added to Maude | 2015-01-05 |
| 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 TNA |
| Generic Name | ELECTROSURGICAL DEVICE |
| Product Code | DWG |
| Date Received | 2014-12-18 |
| Model Number | PS300-002 |
| Catalog Number | PS300-002 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC ADVANCED ENERGY, LLC |
| Manufacturer Address | 180 INTERNATIONAL DRIVER PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-18 |