FDA Adverse Event
Malfunction
Summary report: N
PLASMABLADE TISSUE DISSECTION DEVICE
MDR report key: 2822286
·
Received October 25, 2012
Report
- Report Number
- 3007069406-2012-00452
- Event Type
- Malfunction
- Date Received
- October 25, 2012
- Date of Event
- November 21, 2011
- Report Date
- November 21, 2011
- Manufacturer
- MEDTRONIC ADVANCED ENERGY LLC
- Product Code
- GEI
- PMA / PMN Number
- K083415
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MFR FOR THE TIME PERIOD (B)(4) 2010 THROUGH (B)(4) 2012. THIS PLASMABLADE USED IN THE REPORTED COMPLAINT WAS NOT RETURNED FOR ANALYSIS. END OF REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THE TEFLON COATING WAS FLAKING OFF THE TONSIL TIP. THERE WERE NO PT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLASMABLADE TISSUE DISSECTION DEVICE | GEI | MEDTRONIC ADVANCED ENERGY LLC | PLASMABLADE 3.0S | 49084 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | PULSAR GENERATOR |