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 2014-07-22 for GENERATOR PULSAR II REFURB PS100-102RF manufactured by Medtronic Advanced Energy, Llc.
[4641950]
During a case the surgeon got too close to skin edge during the gracilis flap dissection and burned the flap being excised from the inside out. The burn was about 5mm x 5mm in size. The section of the flap that was burned was excised and the remainder of the flap utilized. No patient impact noted.
Patient Sequence No: 1, Text Type: D, B5
[11976767]
Product event: (b)(4). Method, results, conclusion: facility not returning product. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103812092]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00054 |
| MDR Report Key | 3951124 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-07-22 |
| Date of Report | 2014-06-23 |
| Date of Event | 2014-06-23 |
| Date Mfgr Received | 2014-06-23 |
| Date Added to Maude | 2014-08-01 |
| 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 II REFURB |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-07-22 |
| Model Number | PS100-102RF |
| Catalog Number | PS100-102RF |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2014-07-22 |