MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,company representative, report with the FDA on 2014-08-28 for PLASMABLADE 3.0 WIDE SPATULA PS210-030S manufactured by Medtronic Advanced Energy, Llc.
[4908144]
Plasmablade device was being used on coag 6 and approximately 1 hour into a bilateral mastectomy case it was noticed that the tip coating appeared to have melted. Another plasmablade device was opened and the case continued but the second device had the same melting issue which was discovered near the end of the case. Case was completed successfully with alternative medical device. The second device is being returned for investigation. The first device was discarded by the facility. The device that is scheduled for return and investigation.
Patient Sequence No: 1, Text Type: D, B5
[12278243]
(b)(4). Method, results, conclusion: product scheduled for return but not received by manufacturer for inspection. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[35155673]
Product event # (b)(4). Testing performed: device packaging inspection: plasmablade? 3. 0s was received inside a cardboard (b)(4) box with no packaging to fill the negative space and double bagged within biohazard bags. Tyvek? Lid returned and the product information matches the product information within the product event page listed in gch. Handwritten note included stating? Tip melting?. No other original packaging or paperwork included. Device visual inspection: device appears used with blood on body, handle and cord. Saline and blood present inside the suction tubing. Electrode charring and charred tissue inside the suction shaft. Top level electrode coating is peeled back from the electrode. Heat shrink has splits along the sides from the electrode to the top of the device nose. Both cut and coag buttons have a definitive tactile feel. Plasmablade? 3. 0s will be sent to ft. Worth texas for root cause analysis. Functional inspection: functional inspection was not performed as the complaint was able to be confirmed by visual inspection. Lhr review: a review of the lhr for the plasmablade? 3. 0s? Lot # fl50805926 - revealed there were no problems during manufacturing that can be associated with the reported complaint. Investigation conclusion: the complaint is confirmed for the? Melting? Tip-coating? Issue. During visual inspection it was observed that the electrode insulation, top layer of the coating, was peeled back from the electrode; however it could not be determined what caused the insulation coating to peel. The plasmablade 3. 0s - melting - tip coating? Complaint device has been sent to medtronic ft. Worth texas for complaint root cause analysis for coating defect, see separate report for analysis. Below is the summary of the findings from the failure analysis. Based on optical, electron microscopy and microanalyses, following conclusions can be drawn: presence of silicon and oxygen next to fluorinated areas indicate glass coating is still covering the whole blade surfaces, i. E. , glass coating remained intact. Fluorine is absent on glass exposed area of the blade indicates teflon coating is delaminated on those areas. So the main failure is teflon coating, i. E. , endura coating, not the glass coating. Reference documents: 42-10-1020 rev. C? Work instructions for complaint investigations? Disposable devices 31-10-1369 rev. C? Plasmablade? 3. 0 family - product specification and quality plan lbl-00093 rev. C? Plasmablade? 3. 0s? Ifu? Instructions for use 70-10-1429 rev. B? Pulsar? Ii generator? Operators manual test equipment: no test equipment was utilized as the complaint was confirmed by visual inspection. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[35155674]
Plasmablade device was being used on coag 6 and approximately 1 hour into a bilateral mastectomy case it was noticed that the tip coating appeared to have melted. Another plasmablade device was opened and the case continued but the second device had the same melting issue which was discovered near the end of the case. Case was completed successfully with alternative medical device. The second device is being returned for investigation. The first device was discarded by the facility. This report represents product line #20-the device that is scheduled for return and investigation.
Patient Sequence No: 1, Text Type: D, B5
[103813138]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00078 |
| MDR Report Key | 4043710 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-08-28 |
| Date of Report | 2014-09-30 |
| Date of Event | 2014-07-29 |
| Date Mfgr Received | 2014-09-30 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2014-09-11 |
| 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 | 3 |
| Event Location | 3 |
| 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 3.0 WIDE SPATULA |
| Generic Name | ELECTROSURGICAL DEVICE |
| Product Code | DWG |
| Date Received | 2014-08-28 |
| Returned To Mfg | 2014-08-07 |
| Model Number | PS210-030S |
| Catalog Number | PS210-030S |
| Lot Number | FL50805926 |
| Device Expiration Date | 2017-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-08-28 |