FDA Adverse Event
Malfunction
Summary report: N
PLASMABLADE TISSUE DISSECTION DEVICE
MDR report key: 2821280
·
Received October 25, 2012
Report
- Report Number
- 3007069406-2012-00484
- Event Type
- Malfunction
- Date Received
- October 25, 2012
- Report Date
- November 23, 2009
- Manufacturer
- MEDTRONIC ADVANCED ENERGY LLC
- Product Code
- GEI
- PMA / PMN Number
- K083415
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS MDR IS BEING FILED BASED AS A RESULT OF A RETROSPECTIVE REVIEW OF MARKETING EVALUATIONS RECEIVED BY THE MANUFACTURER. THE PLASMABLADE USED IN THE REPORTED COMPLAINT WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE LOT HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNK. END OF REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THE TIP CHARRED UP AND THE SUCTION KEPT CLOGGING. THE TIP LOST INSULATION WITH CONSTANT RUBBING TO REMOVE TISSUE. THE SURGEON ALSO COMMENTED THAT THE DEVICE DOES NOT COVER ENOUGH SURFACE AREA AND NEEDED TO BE WIDER WITH BETTER CUTTING ABILITY.
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 | 4 YR | PULSAR GENERATOR |