MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-10-30 for PLASMABLADE 3.0 WIDE SPATULA PS210-030S manufactured by Medtronic Advanced Energy.
[20014847]
After 1. 5 hours into the case the coating on the device tip began to curl. The doctor peeled off one entire side of the coating on the device tip. No material is believed to have flaked off or otherwise been left behind during the operation. There was no reported patient impact.
Patient Sequence No: 1, Text Type: D, B5
[20262821]
Product event # (b)(4). Evaluation (method, (result), (cause): device returned to manufacturer and analysis results pending. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[37766848]
Product analysis # (b)(4) complaint confirmed investigation plan: visual inspection functional inspection (if applicable) lhr review complaint device details: device name: plasma blade 3. 0s, product number: (b)(4), lot number: fl50820055, expiration date: 06-23-2017. Quantity returned: 1 testing performed: device packaging inspection: plasma blade 3. 0s pink device received in a (b)(4) shipper box with no packaging to fill the negative space and double bagged within biohazard bags. No original packaging was returned therefore it is not possible to confirm the device information against the information that is listed in the product event page within (b)(4) nor is it possible to confirm the device that was sent back as the reported complaint device. Printed e-mail with device return instructions included. Device visual inspection: device is used with blood on body, handle cord and within the suction tubing. Electrode charring and peeling of the blade coating. All components appear in place and intact. The electrode peeling is related to the complaint description. Both cut and coag buttons have a definitive tactile feel. Functional inspection: functional inspection was not performed as the complaint for peeling coating on tip was able to be confirmed by visual inspection. Performance testing for the weak cut issue, compromises the device integrity, was not performed as the device to be sent to fort worth for root cause analysis for the peeling coating on tip. Lhr review: a review of the lhr for lot # fl50820055 revealed that there were no problems during manufacturing that can be associated with the reported complaint. Investigation conclusion: the complaint is confirmed for the peeling coating on tip 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. A likely cause of the failure for the weak cut performance issue that was reported in the complaint description is likely related to the device peeling coating on tip however this was not investigated so that the device could be sent to fort worth for root cause analysis as performance testing would have compromised the device's integrity for further testing of the blade coating failure. The device has been sent to medtronic fort worth, tx for root cause analysis for the blade failure analysis; see attachment and below is a summary of the findings in the investigation conclusion. 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 plasma blade device was manufactured according to established manufacturing processes.
Patient Sequence No: 1, Text Type: N, H10
[37766849]
After 1. 5 hours into the case the coating on the device tip began to curl. The doctor peeled off one entire side of the coating on the device tip. No material is believed to have flaked off or otherwise been left behind during the operation. There was no reported patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226420-2014-00107 |
| MDR Report Key | 4212477 |
| Report Source | 06,07 |
| Date Received | 2014-10-30 |
| Date of Report | 2014-12-03 |
| Date of Event | 2014-09-29 |
| Date Mfgr Received | 2014-12-03 |
| Device Manufacturer Date | 2014-06-23 |
| Date Added to Maude | 2014-11-13 |
| 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 3.0 WIDE SPATULA |
| Generic Name | ELECTROSURGICAL DEVICE |
| Product Code | DWG |
| Date Received | 2014-10-30 |
| Returned To Mfg | 2014-10-08 |
| Model Number | PS210-030S |
| Catalog Number | PS210-030S |
| Lot Number | FL50820055 |
| Device Expiration Date | 2017-06-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC ADVANCED ENERGY |
| Manufacturer Address | 180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-30 |