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 2014-06-02 for AQUAMANTYS PUMP GENERATOR 40-402-1 manufactured by Medtronic Advanced Energy, Llc.
[16552562]
During a tka procedure the surgeon placed the device down on the surgical field after use. The patient's leg was put down on top of device inadvertently and the weight from the leg caused the activation button on the device to be depressed, the device was activated, and the activation burned the patient (2nd-3rd degree burn). It was not noticed the device was active under the patient's leg until after the end of the case, therefore, it is unknown how long the device was activated underneath the patient's leg. Burn initially treated with santyl nickel ointment, dressing, and kerlex (used to hold dressings in place). The patient was released to his home on (b)(6) 2014. The burn was confirmed to be the following dimensions, 11. 5 by 9. 5 centimeters, and 1 cm deep. Burn affected the fatty tissue and did not reach the fascia/muscle tissue. The burn had green spots of necrotic tissue and the wound did have some fluid discharge that needed to be drained. But the discharge and wound were not infected. The patient is being treated at home by a third party home healthcare.
Patient Sequence No: 1, Text Type: D, B5
[16591556]
(b)(4). (method, result and conclusions): generator still in use at facility and no return required; therefore, analysis unable to be performed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103812009]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00040 |
| MDR Report Key | 3842767 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-06-02 |
| Date of Report | 2014-05-07 |
| Date of Event | 2014-04-29 |
| Date Mfgr Received | 2014-05-07 |
| Date Added to Maude | 2014-07-02 |
| 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 | AQUAMANTYS PUMP GENERATOR |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-06-02 |
| 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 | 1. Required No Informationntervention | 2014-06-02 |