MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-01-09 for PLASMABLADE 4.0 PS200-040 manufactured by Medtronic Advanced Energy, Llc.
[5429361]
During the functional inspection of the plasmablade 4. 0 device, it was identified that the device coating on the electrode had peeled/flaked/chipped off. No patient impact or injury.
Patient Sequence No: 1, Text Type: D, B5
[12730762]
Product analysis #(b)(4) investigation plan: visual inspection functional inspection (if applicable) lhr review complaint device details: device name: plasmablade? 4. 0 product number: ps200-040 lot number: fl50837681 expiration date: 2017-09-01 quantity returned: 1 testing performed: device packaging inspection: plasmablade? 4. 0 device was hand delivered to the complaint handling department. Dispenser four pack box and plastic tray was returned and the device information was confirmed against the information that is listed within gch. No paperwork was provided. Device visual inspection: device is used with charring of the electrode observed. All components appear in place, intact with no damage. There are no visual signs that can be related to the reported complaint description. Both cut and coag buttons have a definitive tactile feel. Functional inspection: the plasmablade? 4. 0 was connected to the complaint lab pulsar? Ii generator and the expected e5 error code, end of life, was displayed indicating that the device had been successfully activated and connected to a generator prior to complaint investigation. The device was tested for functionality; the device was activated in grounded saline at cut setting? 2 and coag setting-1, settings used for testing during manufacturing, with acceptable results. The device was tested for performance using chicken for 10 minutes total activation time enabling alternation between modes at cut setting-10 for 5 minutes and coag setting-10 for 5 minutes with acceptable results. During performance testing it was observed that the glass insulation coating was peeling and flaking off. ? The device is acceptable if the? Glow? , plasma field, around the edge of the blade is observed and an audible high pitch noise is heard coming from the generator when both buttons cut and coag are actuated? , which was observed during functional inspection of the complaint device. Investigation conclusion: the complaint is not confirmed for the? Aex generator? Error code 7? Issue that was reported in the complaint description. The device was tested for functionality and performance and met the product specifications with acceptable results. The device functioned as intended and responded normally during functional inspection, in grounded saline, chicken testing, and when connected to the generator for all activations. The reported complaint conditions were unable to be reproduced within the laboratory environment during the investigation. During performance testing it was observed that the glass insulation coating was peeling and flaking off. A likely cause of the reported error code could potentially be isolated to the aex generator - error code 7? That was used during a design validation for the aex generator while using a plasmablade? 4. 0, it is unknown how far into use when an error code 7 appeared briefly on the aex generator, and then disappeared which may have caused the device to malfunction and lose effectiveness. No corrective action will be taken at this time. The complaint will be tracked and trended in gch (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2015-00001 |
| MDR Report Key | 4401509 |
| Report Source | 07 |
| Date Received | 2015-01-09 |
| Date of Report | 2014-12-12 |
| Date of Event | 2014-12-12 |
| Date Mfgr Received | 2014-12-12 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2015-01-29 |
| 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 | 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 4.0 |
| Generic Name | ELECTROSURGICAL DEVICE |
| Product Code | DWG |
| Date Received | 2015-01-09 |
| Returned To Mfg | 2014-12-15 |
| Model Number | PS200-040 |
| Catalog Number | PS200-040 |
| Lot Number | FL50837681 |
| Device Expiration Date | 2017-09-01 |
| Operator | OTHER |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-01-09 |