MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-01-09 for PLASMABLADE 4.0 PS200-040 manufactured by Medtronic Advanced Energy, Llc.
[5308864]
During analysis of a plasmablade 4. 0 device that was returned for intermittent functionality, it was identified that the device coating had peeled/flaked/chipped. No patient impact or injury.
Patient Sequence No: 1, Text Type: D, B5
[12648334]
(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: fl50785291, expiration date: unknown, quantity returned: (b)(4). Testing performed: device packaging inspection: plasmablade? 4. 0 device received inside a cardboard box with no packaging to fill the negative space and not double bagged within biohazard bags. Device inside plastic tray with tyvek? Lid taped to the tray and the information matches the device information that is listed in the product event page within (b)(4). Printed invoice with device information returned. Device visual inspection: device is used with minimal dried blood on the handle. Charring of the electrode and missing coating. Eschar and tissue build-up inside the heat shrink proximal to the blade. All components appear in place and intact; however, the electrode coating is missing in several locations. The device has flaking; peeling and missing electrode coating 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 pulsar? Ii generator prior to complaint investigation. The device was tested for functionality, per 42-10-1020 rev. C; 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 is acceptable if the? Glow? 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. The device was tested for performance using chicken, per 31-10-1368 rev. D, 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. Time was measured with a control company digital timer. Additionally during complaint investigation it was observed that the electrode coating was flaking, peeling and missing off the electrode in several locations. Investigation conclusion: the complaint is not confirmed for the? Weak cut and coag? Performance issue that was reported in the complaint description. The device was tested for functionality and performance and met the product specifications. A plasma field was present at the electrode and sound and function of the generator was representative of normal operation. The device responded normally during functional inspection, in grounded saline, and chicken testing. No visual, functional or performance malfunctions could be identified during the investigation. The complaint could not be reproduced within the laboratory environment. The complaint will be tracked and trended in (b)(4). Additionally during complaint investigation it was observed that the electrode coating was flaking, peeling and missing off the electrode in several locations. The flaking and peeling of the blade coating may have contributed to the devices diminished performance and intermittent functionality that the customer experienced however; this was not reproduced within the laboratory environment during functional inspection. A likely cause of the failure could possibly be a generator failure at the customer site may have caused the device to malfunction and lose effectiveness. It cannot be determined when the blade glass coating was compromised as this failure was not mentioned in the reported complaint description; however, it was determined that the blade glass coating failure was not a manufacturing process defect and it is possible that this occurred from the blade being bent, perhaps at the customers site, which will compromise the glass insulator or during transit from the customers site to mae for complaint investigation. No corrective action will be taken at this time. The complaint will be tracked and trended in (b)(4). The device has been sent to medtronic (b)(4) for root cause analysis for the blade failure analysis; see attachment and below is a summary of the findings. ? After physical examination of the blade, it is apparent that the blade is slightly bent at the interface of the black heat shrink and the electrode tip. Due to the fact that the blade coating is a glass insulator, if the blade is bent the glass to metal adhesion will be compromised as seen on the complaint device reviewed.? ? All steps of the manufacturing process were verified and found in compliance with the applicable procedures / work instructions / inspections and there is no evidence that this complaint is related to a manufacturing process defect. No abnormalities or non-conformances were found in the device history record of the affected lots related to the reported complaint. The plasmablade? Device was manufactured according to established manufacturing processes.? (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2015-00003 |
| MDR Report Key | 4401541 |
| Report Source | 06,07 |
| Date Received | 2015-01-09 |
| Date of Report | 2014-09-25 |
| Date of Event | 2014-09-11 |
| Date Mfgr Received | 2014-09-25 |
| 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 | 2014-09-17 |
| Model Number | PS200-040 |
| Catalog Number | PS200-040 |
| Lot Number | FL50785291 |
| Operator | HEALTH PROFESSIONAL |
| 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 |