MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-01-16 for GENERATOR PULSAR PS100-100 manufactured by Medtronic Advanced Energy, Llc.
[4033679]
Activation buttons reversed. When cut is pressed, it activates coag. When coag is pressed, it activates cut. Generator does not give any error messages.
Patient Sequence No: 1, Text Type: D, B5
[11426583]
Product scheduled for return but not received by manufacturer for inspection. Eval code results: product scheduled for return but not received by manufacturer for inspection. Eval code conclusion: product scheduled for return but not received by manufacturer for inspection. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00011 |
| MDR Report Key | 3579326 |
| Report Source | 05 |
| Date Received | 2014-01-16 |
| Date of Report | 2013-12-19 |
| Date of Event | 2013-12-18 |
| Date Mfgr Received | 2013-12-19 |
| Device Manufacturer Date | 2011-11-14 |
| Date Added to Maude | 2014-04-18 |
| 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 | GENERATOR PULSAR |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-01-16 |
| Model Number | PS100-100 |
| Catalog Number | PS100-100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-01-16 |