MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-01-07 for AQUAMANTYS GENERATOR 40-402-1 manufactured by Medtronic Advanced Energy, Llc.
[4055094]
Discovered during the end of a breast oncology (sentinel node/axillary dissection) procedure that patient had a burn to their arm. Burn likely attributed to saline run off during device utilization, specifically that the hot saline ran along the retractors and pooled on the patient's arm resulting in a burn. Patient burn treated with topical measures. Facility is unsure which generator was in use at the time of the incident, therefore, it cannot be confirmed which generator the issue occurred with. All generators will be returned for investigation.
Patient Sequence No: 1, Text Type: D, B5
[11495657]
(b)(4). Method, results and conclusion: product received by manufacturer and pending inspection. Product event: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00004 |
| MDR Report Key | 3558876 |
| Report Source | 06,07 |
| Date Received | 2014-01-07 |
| Date of Report | 2013-12-16 |
| Date of Event | 2013-12-13 |
| Date Mfgr Received | 2013-12-16 |
| Date Added to Maude | 2014-04-08 |
| 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 | AQUAMANTYS GENERATOR |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-01-07 |
| Returned To Mfg | 2014-01-06 |
| Model Number | 40-402-1 |
| Catalog Number | 40-402-1 |
| Device Availability | R |
| 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 | 2014-01-07 |