MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-12-22 for PLASMABLADE 4.0 GENERAL SURGERY PS200-040 manufactured by Medtronic Advanced Energy, Llc.
[5145950]
During cleaning of the device tip during surgery the device tip coating flaked off onto the gauze being used for cleaning. No patient impact or injury.
Patient Sequence No: 1, Text Type: D, B5
[12696560]
Product analysis # (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: 53555 expiration date: unknown quantity returned: 1 testing performed: device packaging inspection: plasmablade? 4. 0 device received inside a cardboard box with plastic air cushions to fill the negative space and within two clear plastic bags. Plastic tray, device holster and tyvek? Lid returned and the device information was confirmed against the information that is listed within gch. Product experience form with device information and complaint details included. Device visual inspection: device appears used with charring of the electrode. Electrode coating is damaged, bent with missing glass insulation coating, which visually relates to the reported complaint description, figure # 1 thru figure # 4. Both cut and coag buttons have a definitive tactile feel. Functional inspection: not performed as the reported complaint was confirmed via visual inspection. Lhr review: a review of the lhr for lot # 53555 revealed there were no problems during manufacturing that can be associated with the reported complaint description. Investigation conclusion: the complaint is confirmed for the? Peeling? Coating? Issue that was reported in the complaint description. Visual inspection confirmed that the glass insulation coating on the electrode is peeling and missing from several areas and it also appears that the electrode is bent which may have caused the glass insulation coating to become compromised resulting in the peeling and flaking of the coating. Such devices are quality inspected prior to release to the customer, therefore it is likely that any damage to the electrode glass insulation coating would have been detected during manufacturing assembly and testing or during inspection. A likely cause of the failure could possibly be user misuse in that the electrode was not cleaned according to the ifu recommendations and perhaps it may have been bent during use which compromised the glass insulation coating and caused it to peel and flake off. The ifu recommends bending the shaft and not the tip. Customers are properly trained for proper use 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 | 1226420-2014-00131 |
| MDR Report Key | 4349845 |
| Report Source | 06,07 |
| Date Received | 2014-12-22 |
| Date of Report | 2014-11-25 |
| Date of Event | 2014-11-18 |
| Date Mfgr Received | 2014-11-25 |
| Date Added to Maude | 2015-01-08 |
| 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 GENERAL SURGERY |
| Generic Name | ELECTROSURGICAL DEVICE |
| Product Code | DWG |
| Date Received | 2014-12-22 |
| Returned To Mfg | 2014-11-26 |
| Model Number | PS200-040 |
| Catalog Number | PS200-040 |
| Lot Number | 53555 |
| 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 | 2014-12-22 |