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 3.0 PS210-030S manufactured by Medtronic Advanced Energy, Llc.
[20298366]
During functional analysis of a plasmablade 3. 0s device that was returned for a failure to activate, it was identified that the device coating had peeled/flaked/chipped and the heat shrink melted. No patient impact or injury.
Patient Sequence No: 1, Text Type: D, B5
[20568448]
Product analysis #(b)(4). Investigation plan: visual inspection functional inspection (if applicable) lhr review complaint device details: device name: plasmablade? 3. 0s? Locking mechanism, product number: ps210-030s, lot number: fl50853173,? Design validation build? Locking mechanism, expiration date: 2017-12, quantity returned: (b)(4). Testing performed: device packaging inspection: plasmablade? 3. 0s with locking mechanism device was hand delivered to the complaint handling department. Display box, plastic tray, and tyvek? Lid returned and the device information was confirmed against the information that was listed in the event description within (b)(4). Product number and expiration date was obtained from the tyvek? Lid. Display box labelled as? Not for human use? Engineering samples. No paperwork was provided. Device visual inspection: device appears used and the electrode is bent. 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? 3. 0s 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 by a pulsar? Ii generator prior to complaint investigation. The device was tested for functionality; the device was activated in grounded saline in the collapsed position, 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-5 for 2. 5 minutes, cut setting-10 for 2. 5 minutes and coag setting-10 for 5 minutes with acceptable results. During performance testing it was observed that the teflon coating on the electrode was peeling and flaking off and the heat shrink melted. There was no disruption of rf energy from the device and generator any time during use that was observed. The device is acceptable if the? Glow? Around the edge of the blade, plasma field, 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? Failure to cut and coag? 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 complaint was unable to be reproduced within the laboratory environment and there was no weak cut and coag performance issues observed during functional inspection. During complaint investigation it was observed that the teflon coating was peeling and the heat shrink melted. It is plausible to suggest a likely cause of the failure to cut and coag could potentially be isolated to the pulsar? Ii generator that was used during a design validation while using a plasmablade? 3. 0s with locking mechanism which may have caused the device to malfunction and loose effectiveness as this was confirmed in the brief description which stated a pulsar? I generator was used to complete the design validation successfully with the same plasmablade? 3. 0s hand piece. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[38796989]
(b)(4). Investigation plan: visual inspection functional inspection (if applicable) lhr review complaint device details: device name: plasmablade? 3. 0s? Locking mechanism product number: ps210-030s lot number: fl50853173? Design validation build? Locking mechanism expiration date: 2017-12 quantity returned: 1 testing performed: device packaging inspection: plasmablade? 3. 0s with locking mechanism device was hand delivered to the complaint handling department. Display box, plastic tray, and tyvek? Lid returned and the device information was confirmed against the information that was listed in the event description within (b)(4). Product number and expiration date was obtained from the tyvek? Lid. Display box labelled as? Not for human use? Engineering samples. No paperwork was provided. Device visual inspection: device appears used and the electrode is bent. 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? 3. 0s 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 by a pulsar? Ii generator prior to complaint investigation. The device was tested for functionality; the device was activated in grounded saline in the collapsed position, 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-5 for 2. 5 minutes, cut setting-10 for 2. 5 minutes and coag setting-10 for 5 minutes with acceptable results. During performance testing it was observed that the teflon coating on the electrode was peeling and flaking off and the heat shrink melted. There was no disruption of rf energy from the device and generator any time during use that was observed. The device is acceptable if the? Glow? Around the edge of the blade, plasma field, 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. Lhr review: a review of the lhr for lot # fl50853173 is not applicable as this build was for design validation testing. Investigation conclusion: the complaint is not confirmed for the? Failure to cut and coag? 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 complaint was unable to be reproduced within the laboratory environment and there was no weak cut and coag performance issues observed during functional inspection. During complaint investigation it was observed that the teflon coating was peeling and the heat shrink melted. It is plausible to suggest a likely cause of the failure to cut and coag could potentially be isolated to the pulsar? Ii generator that was used during a design validation while using a plasmablade? 3. 0s with locking mechanism which may have caused the device to malfunction and loose effectiveness as this was confirmed in the brief description which stated a pulsar? I generator was used to complete the design validation successfully with the same plasmablade? 3. 0s hand piece.
Patient Sequence No: 1, Text Type: N, H10
[38796990]
During functional analysis of a plasmablade 3. 0s device that was returned for a failure to activate, it was identified that the device coating had peeled/flaked/chipped and the heat shrink melted. No patient impact or injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226420-2015-00002 |
| MDR Report Key | 4401510 |
| Report Source | 07 |
| Date Received | 2015-01-09 |
| Date of Report | 2015-05-01 |
| Date of Event | 2014-12-12 |
| Date Mfgr Received | 2015-05-01 |
| 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 3.0 |
| Generic Name | ELECTROSURGICAL DEVICE |
| Product Code | DWG |
| Date Received | 2015-01-09 |
| Returned To Mfg | 2014-12-15 |
| Model Number | PS210-030S |
| Catalog Number | PS210-030S |
| Lot Number | FL50853173 |
| Operator | OTHER |
| Device Availability | R |
| 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 DRIVE PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-09 |