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 3.0S PS210-030SE manufactured by Medtronic Advanced Energy, Llc.
[5308875]
During functional analysis of a plasmablade 3. 0s device returned for a loose shaft and error code, it was identified that the device coating had peeled/flaked/chipped off. No patient impact or injury.
Patient Sequence No: 1, Text Type: D, B5
[12647342]
(b)(4). Investigation plan: visual inspection functional inspection (if applicable) lhr review complaint device details: device name: plasmablade 3. 0s product, number: ps210-030se, lot number: 0208534690,? (b)(4) expiration date: 2017-05-01, quantity returned: (b)(4) testing performed: device packaging inspection: returned in a cardboard box with no packaging to fill the negative space device is within a single bio- hazard bag which is inside its original single display carton device name and lot number on display carton matches the information in the (b)(4) no additional paperwork was included device visual inspection: device appears to have been used with dried blood on hand piece and charred blood on the electrode the electrode blade coating is peeled back and exposes the bare metal on the blade there are no visual signs of a loose telescopic shaft and when shaft is extended it feels firm within the hand piece both cut and coag buttons have a tactile feel functional inspection: the force to? Extend and collapse? The telescoping shaft test was performed as follows: device shaft was pulled out to extended length and firmly pulled using the finger grip. The shaft continued to stay in place within the device. This indicated that the contact slider weld was still holding the shaft in place. While extending and collapsing the device, the tactile feel was smooth and easy to extend and collapse. The shaft mechanism was lubricated with fluids (possibly blood and/or saline). With the device secured in the force meter and 3. 0 pull force fixture, the shaft was manually extended and peak force (lbs. ) was recorded. The force meter was reset (zeroed) and the shaft was collapsed. The peak force (lbs. ) was recorded. The force to extend and collapse the shaft was measured ten times to determine if the device was within specification. The product specification and quality plan? Plasmablade 3. 0? 31-10-1369 rev. C- engineering requirements? ? The force to extend and collapse the telescoping shaft must be between 1. 0 and 6. 0 lbs. And must withstand 10 cycles of extending and collapsing the shaft.? 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 and connected to a pulsar? Ii generator previously. The device was tested for functionality, per 42-10-1020 rev. C; 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 to the? Glow? Around the edge of the blade. ? 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. There were no error codes displayed from the generator during the functional inspection. Lhr review: an lhr review for lot # 0208534690? (b)(4) revealed that there were no problems during manufacturing that can be associated with the reported complaint description. Investigation conclusion: complaint is confirmed - the complaint is confirmed for the? Loose shaft? Issue that was reported in the complaint description. According to the product specification and quality plan - plasmablade 3. 0, (31-10-1369 rev. D),? The force to extend and collapse the telescoping shaft must be between 1. 0 and 6. 0 lbs. And must withstand 10 cycles of extending and collapsing the shaft?. The device fails to meet the product specifications of 31-10-1369 rev. D as seen by the results attained. It is likely the bodily/saline fluid on the shaft cause the shaft to be overwhelmed with lubrication giving a loose feeling and effect during use. A warning is listed in the lbl-00166 rev. C? Plasmablade 3. 0s, which states:? Avoid fluid contact with the handle and its interfaces and connections as this may result in patient or user injury, or device failure?. Situational analysis 13-90-0033 rev. A has been initiated to address plasmablade? 3. 0 devices that have been reported to have a loose device shaft and/or have a device shaft with loose rotation; therefore, this complaint will be associated with the sa. There were no unknown error codes encountered during the functional testing to support the? Unknown error code? Issue in the description. It is likely that the failure is isolated to the customer? S generator. Additionally peeling? Coating on tip was observed during functional inspection. The electrode insulation, glass coating, and the top layer of teflon coating, was peeled back from the electrode; however, it could not be determined what caused the insulation coating to peel. The device has been sent to medtronic (b)(4) for root cause analysis for the blade failure analysis;? 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 | 1226420-2015-00004 |
| MDR Report Key | 4401550 |
| Report Source | 06,07 |
| Date Received | 2015-01-09 |
| Date of Report | 2014-10-09 |
| Date of Event | 2014-10-09 |
| Date Mfgr Received | 2014-10-09 |
| Device Manufacturer Date | 2014-07-15 |
| 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 3.0S |
| Generic Name | ELECTROSURGICAL DEVICE |
| Product Code | DWG |
| Date Received | 2015-01-09 |
| Returned To Mfg | 2014-10-22 |
| Model Number | PS210-030SE |
| Catalog Number | PS210-030SE |
| Lot Number | 0208534690 |
| Device Expiration Date | 2017-05-01 |
| 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 PORSTMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-09 |