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 2014-08-12 for GENERATOR PULSAR REFURBISHED PS100-100RF manufactured by Medtronic Advanced Energy, Llc.
[19804903]
When the coag activation button of the device was released, the coag feature on the generator screen displayed as though the system was still active in coag mode. It is not known if the system was still delivering rf energy after handpiece button was release or if rf energy was still being delivered upon handpiece activation button release.
Patient Sequence No: 1, Text Type: D, B5
[19913149]
Product event: (b)(4). Method, conclusions: product received by manufacturer and pending inspection. Eval code results: product received by manufacturer and pending inspection. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[37081425]
(b)(4) evaluation process: unit received in standard shipping container. Unit received in fair condition with minor surface imperfections. Power cord received with unit. No user manual nor power cord were received. Internal visual inspection found nothing moving or broken in unit. Unit delivered rf energy correctly into fixed resistors. Unit tested with both socketed monopolar handpiece and plasmablade 4. 0 handpiece. Plasmablade 4. 0 handpiece was also tested with saline bath media. Generator functioned normally in all instances of both coag and cut operation. Could not replicate interference problem. Root cause: despite extensive, varied testing, the service department as unable to replicate the described complaint with coag energy being delivered after button released. Since this is the second time that the unit has been returned with this (unconfirmed) complaint, it is recommended that this unit be removed from service. The real-time clock battery died due to age. The pulsar is an electro surgery device and, as such, is considered an intentional radiator of rf energy when keyed (via foot pedal or handpiece button activation. ) all equipment in the or should be designed to withstand the emi interference generated by the pulsar rf generator (per iec 60601 requirements). The pulsar rf generator is functioning as designed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[37081426]
When the coag activation button of the device was released, the coag feature on the generator screen displayed as though the system was still active in coag mode. It is not known if the system was still delivering rf energy after handpiece button was release or if rf energy was still being delivered upon handpiece activation button release.
Patient Sequence No: 1, Text Type: D, B5
[103812655]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00065 |
| MDR Report Key | 4004203 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-08-12 |
| Date of Report | 2014-09-18 |
| Date of Event | 2014-07-14 |
| Date Mfgr Received | 2014-09-18 |
| Date Added to Maude | 2014-08-26 |
| 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 | 2014-08-12 |
| Returned To Mfg | 2014-07-31 |
| 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 | 2014-08-12 |