MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-12-15 for PLASMABLADE 3.0S PS210-030P manufactured by Medtronic Advanced Energy (salient).
[20749277]
During routine biomed testing of the pulsar generator and plasmablade cut levels 1-5 were higher than the expected output value. All other settings were within specifications. An rf 303 biotech esu was used for testing with a 3. 0 device. There were no error codes. The unit was plugged directly into the wall for testing. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[20998908]
Product event # (b)(4). Evaluation, (method), (result), (conclusion): device discarded therefore analysis unable to be performed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[37880203]
(b)(4) investigation plan: visual inspection functional inspection (if applicable) lhr review complaint device details: device name: plasmablade plus product number: ps210-030p lot number: fl50805922 expiration date: 2017-05-01 quantity returned: 2 testing performed: device packaging inspection: two devices were returned in a fedex box wrapped in bubble wrap to take up the negative space both devices were in a single clear, non-bio-hazard zip lock bag with one device in its original clear tray with its tyvek lid and no ball electrodes were included the lot number and the device name match the information listed in the corresponding product event page within gch from the tyvek lid no additional paperwork was included both plasmablade plus devices are numbered for traceability device visual inspection: device #1: device appears to be clean and not used all components appear intact without any damage there are no visual signs related to the description both cut and coag buttons have a tactile feel device #2: device appears to be clean and not used all components appear intact without any damage there are no visual signs related to the description both cut and coag buttons have a tactile feel functional inspection: device #1: the plasmablade 3. 0p was connected to the complaint lab pulsar generator and the expected e5 error code,? End of life? , was displayed indicating that the device had been successfully activated by a pulsar 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 additionally tested at cut settings 1 thru 10 and coag settings 1 thru 10 with acceptable results 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. Device #2: the plasmablade 3. 0p was connected to the complaint lab pulsar generator and the expected e5 error code,? End of life? , was displayed indicating that the device had been successfully activated by a pulsar 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 additionally tested at cut settings 1 thru 10 and coag settings 1 thru 10 with acceptable results 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 the plasmablade 3. 0p- lot # fl50805922 revealed that there were no problems during manufacturing that can be associated with the reported complaint. Investigation conclusion: the complaint is not confirmed for the? Failed biomed test? High output? Issue for both plasmablade plus devices. The reported failure was unable to be reproduced within the laboratory environment. The devices were tested for functionality and met the product specifications with acceptable results. The devices functioned as intended and responded normally during functional inspection, in grounded saline and when connected to the generator for all activations. No visual or functional issues could be identified to support the complaint during the investigation. A likely cause of the failure may possibly be a generator failure at the customer site that caused the device to malfunction, loose effectiveness and produce the high output reading during biomed testing. No corrective action will be taken at this time. The complaint will be tracked and trended in gch.
Patient Sequence No: 1, Text Type: N, H10
[37880204]
During routine biomed testing of the pulsar generator and plasmablade cut levels 1-5 were higher than the expected output value. All other settings were within specifications. An rf 303 biotech esu was used for testing with a 3. 0 device. There were no error codes. The unit was plugged directly into the wall for testing. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226420-2014-00122 |
| MDR Report Key | 4329041 |
| Report Source | 06,07 |
| Date Received | 2014-12-15 |
| Date of Report | 2015-04-03 |
| Date of Event | 2014-11-17 |
| Date Mfgr Received | 2015-04-03 |
| Device Manufacturer Date | 2014-05-01 |
| 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 | 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 3.0S |
| Generic Name | ELECTROSURGICAL DEVICE |
| Product Code | DWG |
| Date Received | 2014-12-15 |
| Returned To Mfg | 2015-01-21 |
| Model Number | PS210-030P |
| Catalog Number | PS210-030P |
| Lot Number | FL50805922 |
| Device Expiration Date | 2017-05-01 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-12-15 |