FDA Adverse Event
Other
Summary report: N
PLASMABLADE TISSUE DISSECTION DEVICE
MDR report key: 2582930
·
Received May 16, 2012
Report
- Report Number
- 3007069406-2012-00091
- Event Type
- Other
- Date Received
- May 16, 2012
- Report Date
- April 17, 2012
- Manufacturer
- MEDTRONIC ADVANCED ENERGY LLC
- Product Code
- GEI
- PMA / PMN Number
- K083415
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A TONSIL TIP IGNITION WAS REPORTED TO THE MFR. NO PT IMPACT. THE MFR IS AWAITING RETURN OF THE DEVICE FOR EVAL. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TONSIL TIP IGNITED. NO PT IMPACT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLASMABLADE TISSUE DISSECTION DEVICE | GEI | MEDTRONIC ADVANCED ENERGY LLC | PLASMABLADE TNA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | NOT AVAILABLE |