FDA Adverse Event
Malfunction
Summary report: N
BIPOLAR SEALER AQM MBS W/LIGHT
MDR report key: 4134120
·
Received October 2, 2014
Report
- Report Number
- 1226420-2014-00091
- Event Type
- Malfunction
- Date Received
- October 2, 2014
- Date of Event
- October 2, 2012
- Report Date
- September 4, 2014
- Manufacturer
- MEDTRONIC ADVANCED ENERGY, LLC
- Product Code
- DWG
- PMA / PMN Number
- K073495
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). METHOD, RESULTS: FACILITY DISPOSED OF DEVICE. DEVICE IS NOT AVAILABLE FOR RETURN AND INSPECTION. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
SURGEON REPORTED THAT A PATIENT PRESENTING WITH A POST-OPERATIVE WOUND INFECTION AFTER A MULTI-LEVEL SPINE PROCEDURE WHERE THE AQUAMANTYS SYSTEM WAS UTILIZED. THE REPORTED ISSUE OCCURRED 2 YEARS AGO, BUT MEDTRONIC SALES REPRESENTATIVE FIRST NOTIFIED (B)(6) 2014. NO FURTHER INFORMATION IS AVAILABLE FROM THE FACILITY WHERE THE REPORTED ISSUE OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 616847 | BIPOLAR SEALER AQM MBS W/LIGHT | ELECTROSURGICAL DEVICE | DWG | MEDTRONIC ADVANCED ENERGY, LLC | 23-301-1 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |