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 2014-08-28 for GENERATOR AQM 115V 40-402-1 manufactured by Medtronic Advanced Energy, Llc.
[4908686]
Surgeon reports he is no longer using aquamantys as he had two patients present with an unknown infection after use of the aquamantys 6. 0. The issue happened over a year ago, but was first reported to medtronic 8/4/2014. No further information available regarding case details or patient demographics. The patient infections have healed and patients are reported to be doing fine now with no further impact. Due to lack of detailed patient information, both cases are being reported via this one mdr report.
Patient Sequence No: 1, Text Type: D, B5
[12278245]
Product event: (b)(4). Method,results,conclusion: generator still in use and facility not returning for investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103813264]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00080 |
| MDR Report Key | 4043716 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-08-28 |
| Date of Report | 2014-08-04 |
| Date of Event | 2014-08-04 |
| Date Mfgr Received | 2014-08-04 |
| Date Added to Maude | 2014-09-12 |
| 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 AQM 115V |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-08-28 |
| Model Number | 40-402-1 |
| Catalog Number | 40-402-1 |
| 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 | 2014-08-28 |