FDA Adverse Event
Injury
Summary report: N
PLASMABLADE 3.0S
MDR report key: 2966254
·
Received February 18, 2013
Report
- Report Number
- 1226420-2013-00034
- Event Type
- Injury
- Date Received
- February 18, 2013
- Date of Event
- January 24, 2013
- Report Date
- February 13, 2013
- Manufacturer
- MEDTRONIC ADVANCED ENERGY, LLC
- Product Code
- DWG
- PMA / PMN Number
- K093695
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). METHOD: FACILITY DISPOSED OF DEVICE. DEVICE IS NOT AVAILABLE FOR RETURN AND INSPECTION. RESULTS: FACILITY DISPOSED OF DEVICE. DEVICE IS NOT AVAILABLE FOR RETURN AND INSPECTION. PRODUCT EVENT: (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
DOCTOR HIT AORTA WITH PLASMABLADE DURING A CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 70288 | PLASMABLADE 3.0S | ELECTROSURGICAL DEVICE | DWG | MEDTRONIC ADVANCED ENERGY, LLC | PS210-030SE | 0206179995 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |