MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-12-03 for PLASMABLADE 4.0 PS200-040 manufactured by Medtronic Advanced Energy, Llc.
[5079584]
During a surgical procedure a nurse wiped the plasmablade with wet gauze to remove blood and subsequent to the wiping it was noticed that the device coating had flaked off. It is unknown if the coating peeled off during cleaning of the device or prior to cleaning.
Patient Sequence No: 1, Text Type: D, B5
[12595546]
Product event: (b)(4). Investigation plan: visual inspection functional inspection (if applicable) lhr review complaint device details: (obtain information from the product line items in gch) please note if there are any discrepancies between the returned device(s), and the device(s) listed within gch. Device name: plasmablade? 4. 0 product number: ps200-040, lot number: 53556 expiration date: unknown quantity returned: 1 testing performed: visual inspection: (device visual inspection must be filled out for each device returned) device packaging inspection: plasmablade? 4. 0 device received inside a (b)(4) shipper box with plastic air cushions to fill the negative space and not within biohazard bags. Plastic tray, holster and tyvek? Lid returned and the device information was confirmed against the information that is listed within gch. Expiration date from tyvek? Lid? 2015-02 product return form included. Device visual inspection: device is used with blood and eschar build-up on the electrode. Electrode is damaged as the coating is peeling and appears to have been scratched likely with an abrasive material which visually relates to the complaint description. Heat shrink has damage as it appears to have been scratched with an abrasive material which also visually relates to the complaint description. Both cut and coag buttons have a definitive tactile feel. Functional inspection: (if inspection performed, must be filled out for each device tested) not performed as the reported complaint was confirmed via visual inspection. Lhr review: (lot number of returned product or what is populated as the lot number in gch), any deviations, failures, scrap, etc. Pertaining to complaint description) a review of the lhr for lot # 53556 revealed that there were no problems during manufacturing that can be associated with the reported complaint description. Investigation conclusion: (complaint confirmed - not confirmed, summary of findings, likely cause of failure, impact of failure to the functionality of the device, recommendations) the complaint is confirmed for the? Peeling? Coating? Issue that was reported in the complaint description. Visual inspection confirmed that the glass coating insulation on the electrode is peeling and missing from several areas and appears to have been scratched with an abrasive material, as evidenced in the pictures, figure # 1 thru figure # 4. The physical characteristics of the heat shrink and electrode indicate that a scratch pad or other abrasive material was used to clean the electrode during the procedure. The use of a scratch pad to clean the electrode tip will cause damage to the heat shrink and glass coating on the electrode as a scratch pad is extremely abrasive. Such devices are quality inspected prior to release to the customer, therefore it is likely that due to the severity of damage the electrode glass coating insulation and the heat shrink sustained in this case would have been detected during manufacturing assembly and testing or during inspection. A likely cause of the failure could be user misuse in that the electrode was not cleaned according to the ifu recommendations. Customers are properly trained prior to using the peak surgery system which includes reading and understanding the ifu. The ifu outlines proper cleaning and use of the plasmablade? And specifically relates to the reported complaint as listed below: lbl-00116 rev. B? Plasmablade? 4. 0? Ifu? Precautions and warnings when bending the peak plasmablade shaft, do not exceed a 45? Angle with the plane of the shaft. Do not bend more than three times. Bend the shaft, not the tip. Excessive bending of the shaft may compromise performance of the device or cause device failure, which could result in patient or user injury. Use finger force to shape the shaft; do not use forceps as this could damage the device. Do not use sharp or abrasive instruments or materials to clean eschar buildup on the electrode tip as this may damage the tip. Prior to use, inspect the peak plasmablade for any defects. Do not use if insulation or connectors are damaged. Take care when handling the electrode tip to prevent possible damage to the tip and to prevent user injury. Eschar buildup on the tip can be removed manually with gloved fingers or gauze pads, or by inserting the tip into the slot at the front of the holster and drawing the device backwards through the slot. Inspect the device for any signs of damage after cleaning. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00118 |
| MDR Report Key | 4293560 |
| Report Source | 06,07 |
| Date Received | 2014-12-03 |
| Date of Report | 2014-11-05 |
| Date of Event | 2014-10-30 |
| Date Mfgr Received | 2014-11-05 |
| Date Added to Maude | 2014-12-12 |
| 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 | 2014-12-03 |
| Returned To Mfg | 2014-11-05 |
| Model Number | PS200-040 |
| Catalog Number | PS200-040 |
| Lot Number | 53556 |
| 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 | 2014-12-03 |