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.
[5308876]
During functional analysis of a plasmablade 4. 0 device that was returned for a failure to connect, 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
[12730764]
(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: fl50828848, expiration date: 2017-08-07, quantity returned: (b)(4) testing performed: device packaging inspection: plasmablade? 4. 0 pink device received inside a (b)(4) mailer envelope with no packaging to fill the negative space and not within biohazard bags. Plastic tray, holster, and tyvek? Lid returned and the device information matches the information that is listed within (b)(4). Handwritten note on the tyvek? Lid? Unable to plug in? No paperwork provided. Device visual inspection: device appears clean with no visible blood. Electrode has peeling and chipping on the glass coating. The device will be sent to (b)(4) for rca for blade coating failure analysis. The device plug connector has three visibly bent, flattened and sheared connector pins that are related to the complaint description, figure # 1. Both cut and coag buttons have a definitive tactile feel. Functional inspection: the reported complaint device, plasmablade? 4. 0, was attempted to connect to the complaint lab pulsar? Ii generator but was unsuccessful. The device plug connector pins would not line up with the receptacle, mating connector, on the generator to enable a connection. The complaint lab pulsar? Ii generator screen displayed dashes for settings and there was no audible tone heard coming from the generator which indicates there was not a successful connection to the generator. There are three visibly bent, flattened and sheared device plug connector pins, pin # 2, pin # 5 and pin # 6, figure # 1, which prevents connection to the generator. Lhr review: a review of the lhr for lot # fl50828848 revealed that there were no problems during manufacturing that can be associated with the reported complaint description. Investigation conclusion: the complaint is confirmed for the? Failure to connect? Issue. Visual and functional inspection of the device plug connector confirmed that the device could not be plugged into the complaint lab pulsar? Ii generator successfully. From the investigation results the likely cause of the failure is that the device plug connector has three bent, flattened and sheared device plug connector pins, pin # 2, pin # 5 and pin # 6, figure # 1, which prevents connection to the receptacle, mating connector, on the generator resulting in the device? S failure to function as expected. This failure mode could occur from rough handling during manufacturing testing or during use or misalignment of the pins at the connector manufacturer. The complaint will be tracked and trended in (b)(4) additionally during complaint investigation the blade coating peeling and chipping was observed. The device was sent to (b)(4) for blade coating failure analysis? Rca. The device has been sent to medtronic (b)(4) for root cause analysis for the blade failure analysis; all steps in the manufacturing process were verified and found in compliance with the applicable procedures, work instructions and 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. Plasmablade? Device was manufactured according to established manufacturing process. From the investigation results the likely cause of the failure is the bent electrode tip. Per the ifu for plasmablade? 4. 0 warning section? Bend the shaft, not the tip.? Additionally under? Shaping the shaft section of the ifu it is stated? Note: do no bend the electrode tip as this may damage the tip.? (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2015-00005 |
| MDR Report Key | 4401554 |
| Report Source | 06,07 |
| Date Received | 2015-01-09 |
| Date of Report | 2014-10-21 |
| Date of Event | 2014-10-21 |
| Date Mfgr Received | 2014-10-21 |
| Device Manufacturer Date | 2014-08-07 |
| 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 | 2014-10-28 |
| Model Number | PS200-040 |
| Catalog Number | PS200-040 |
| Lot Number | FL50828848 |
| Device Expiration Date | 2017-08-07 |
| 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 |