MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,company representative, report with the FDA on 2014-06-24 for GENERATOR PULSAR REFURBISHED PS100-100RF manufactured by Medtronic Advanced Energy, Llc.
[4545926]
Doctor reported that he had a situation where the plasmablade sparked while dissecting out a patient ipg leads. After connecting the newly implanted lead to the ipg, it was impossible to turn on the patient's device or even check impedances without her getting painful shock/jolt on the affected side of her body. Device was left off and the patient returned at a later date and the same results occurred. It is unknown how the situation will be resolved. The surgeon elected to use the system again (b)(6) 2014 for two cases after some discussions around settings (surgeon used a cut/coag 5 versus our recommended cut/coag 6) and everything went fine.
Patient Sequence No: 1, Text Type: D, B5
[4728552]
Doctor reported that he had a situation where the plasmablade sparked while dissecting out a patient ipg leads. After connecting the newly implanted lead to the ipg, it was impossible to turn on the patient? S device or even check impedances without her getting painful shock/jolt on the affected side of her body. Device was left off and the patient returned at a later date and the same results occurred. It is not confirmed how the situation will be/was resolved. The surgeon elected to use the system again (b)(6) 2014 for two cases. After some discussions around settings (surgeon used a cut/coag 5 versus our recommended cut/coag 6) and everything went fine.
Patient Sequence No: 1, Text Type: D, B5
[12023321]
(b)(4). Method: facility not returning product as it was used subsequently with no further issues. Eval code results: facility not returning product as it was used subsequently with no further issues. Conclusion: facility not returning product as it was used subsequently with no further issues. Product event: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[12261464]
Product event #(b)(4) evaluation process: unit received in standard shipping container. Unit received in fair condition with minor surface imperfections including staining to lower case. Power cord and user manual were received with unit. No hand pieces were received. Internal visual inspection fund nothing moving or broken in unit. Unit delivered rf energy correctly into fixed resistors. Qualitative observation, while delivering energy to a saline bath, showed known amounts of arcing. Unit generated a small arc when touched to metal plate under analog substance. This experiment was repeated, with similar results, with pulsar generator number 09p00479. The error log revealed that the unit was powered up on at least 1 unique day while in the field (the error log indicates that the ucb battery died after unit shipped to the customer on(b)(6) 2013 but before first use in the field. ) error log contains 2 e3s (patient return electrode has poor connection) and 2 e11s (patient return electrode disconnected. ) all error log entries are considered? Normal use? Errors and are not indicative of a problem with the unit. Root cause: if the power level on the pulsar generator is high enough, the plasmablade will emit an arc when near a metal plate in a saline bath (acting as a patient analog. ) no performance issues noted with the generator. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[86580045]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00041 |
| MDR Report Key | 3889960 |
| Report Source | 05,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-06-24 |
| Date of Report | 2014-08-20 |
| Date of Event | 2014-05-21 |
| Date Mfgr Received | 2014-08-20 |
| Device Manufacturer Date | 2010-01-27 |
| Date Added to Maude | 2014-07-21 |
| 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 | GENERATOR PULSAR REFURBISHED |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-06-24 |
| Returned To Mfg | 2014-07-10 |
| Model Number | PS100-100RF |
| Catalog Number | PS100-100RF |
| 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 | 2014-06-24 |