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 2014-12-22 for PLASMABLADE PLUS PS210-030P manufactured by Medtronic Advanced Energy, Llc.
[5223111]
About an hour into the procedure it was identified that the coating on the device tip was peeling/flaking/chipping. The device was swapped out to complete the case. No patient impact or injury.
Patient Sequence No: 1, Text Type: D, B5
[12698614]
(b)(4). Eval, method: product scheduled for return but not received by manufacturer for inspection. Eval, results: product scheduled for return but not received by manufacturer for inspection. Eval, conclusion: product scheduled for return but not received by manufacturer for inspection. Product event: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[25247945]
Product event #(b)(4)investigation plan: visual inspection functional inspection (if applicable) lhr review complaint device details: device name: plasmablade? 3. 0p product number: ps210-030p lot number: fl50786679 expiration date: 2017-02-01 quantity returned: 1 testing performed: device packaging inspection: plasmablade? 3. 0p received inside a padded mailer envelope with no packaging to fill the negative space and within a single clear plastic bag and then within a biohazard bag. No original packaging was returned therefore it is not possible to confirm the device information against the information that is listed within gch nor is it possible to confirm the device that was sent back as the reported complaint device. No paperwork was included. Device visual inspection: device appears used with blood on body, handle, cord and suction tubing with charring of the electrode. Device cord and saline tubing has been cut off the device which impedes functional inspection, figure # 1. There is no evidence of the electrode coating peeling, figure # 2 and figure # 3. Both cut and coag buttons have a definitive tactile feel. Functional inspection: functional inspection was not possible as the device cord was cut off the device which impedes functional inspection. Lhr review: a review of the lhr for lot # fl50786679 revealed: 20. 3. 6? Sub assembly? Functional testing? Firing? 1 scrap device investigation conclusion: the complaint is not confirmed for the? Peeling coating? Weak cut and coag? Issues that was reported in the complaint description. The device was unable to be tested for functionality, performance as well as reproduced within the laboratory environment as functional inspection was impeded because the device cord was cut off the device. The device electrode was examined for the peeling coating issue and there was no evidence that the teflon coating was peeling off the device electrode. The electrode edge shows evidence of use with eschar build-up yet there is no indication of the electrode coating peeling. The complaint will be tracked and trended within gch. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[25247946]
About an hour into the procedure it was identified that the coating on the device tip was peeling/flaking/chipping. The device was swapped out to complete the case. No patient impact or injury.
Patient Sequence No: 1, Text Type: D, B5
[103815033]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00132 |
| MDR Report Key | 4349854 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-12-22 |
| Date of Report | 2015-04-13 |
| Date of Event | 2014-11-26 |
| Date Mfgr Received | 2015-04-13 |
| Device Manufacturer Date | 2014-02-12 |
| 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 | 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 PLUS |
| Generic Name | ELECTROSURGICAL DEVICE |
| Product Code | DWG |
| Date Received | 2014-12-22 |
| Returned To Mfg | 2015-02-04 |
| Model Number | PS210-030P |
| Catalog Number | PS210-030P |
| Lot Number | FL50786679 |
| Device Expiration Date | 2017-02-01 |
| 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, LLC |
| Manufacturer Address | 180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-22 |