FDA Adverse Event
Other
Summary report: N
PLASMABLADE TISSUE DISSECTION DEVICE
MDR report key: 2467807
·
Received February 21, 2012
Report
- Report Number
- 3007069406-2012-00033
- Event Type
- Other
- Date Received
- February 21, 2012
- Date of Event
- January 27, 2012
- Report Date
- January 30, 2012
- Manufacturer
- MEDTRONIC ADVANCED ENERGY LLC
- Product Code
- GEI
- PMA / PMN Number
- K083415
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE FACILITY DID NOT RETAIN THE DEVICE FOR EVAL; A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE LOT NUMBER FOR THE REPORTED COMPLAINT WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE LOT HISTORY RECORD WAS NOT CONDUCTED. A CORRECTIVE ACTION REPORT HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS TYPE OF FAILURE MODE ((B)(4)).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE PROCEDURE, THE ADENOID TIP CAUGHT FIRE. 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 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | NOT AVAILABLE |