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 MAE UNKNOWN PEAK PULSAR GENERATOR MAE UNK PEAK GEN manufactured by Medtronic Advanced Energy, Llc.
[5038441]
During a case, the surgeon reported that there was reversed activation on the pulsar generator, specifically when the cut button is pressed, the generator shows coag mode is activated and when the coag is pressed, the generator shows cut mode is activated. No patient impact, patient information unavailable.
Patient Sequence No: 1, Text Type: D, B5
[12479820]
(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
| Report Number | 1226420-2014-00105 |
| MDR Report Key | 4212430 |
| Report Source | 06,07 |
| Date Received | 2014-10-30 |
| Date of Report | 2014-10-01 |
| Date of Event | 2014-10-01 |
| Date Mfgr Received | 2014-10-01 |
| 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 | MAE UNKNOWN PEAK PULSAR GENERATOR |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-10-30 |
| Model Number | MAE UNK PEAK GEN |
| Catalog Number | MAE UNK PEAK GEN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC ADVANCED ENERGY, LLC |
| Manufacturer Address | 180 INTERNATIONAL DRIVER PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-30 |