FDA Adverse Event
Malfunction
Summary report: N
PLASMABLADE TISSUE DISSECTION DEVICE
MDR report key: 2821266
·
Received October 25, 2012
Report
- Report Number
- 3007069406-2012-00437
- Event Type
- Malfunction
- Date Received
- October 25, 2012
- Report Date
- April 13, 2010
- Manufacturer
- MEDTORNIC ADVANCED ENERGY LLC
- Product Code
- GEI
- PMA / PMN Number
- K083695
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
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.
Description of Event or Problem · 1
IT WAS REPORTED FROM A CUSTOMER EVALUATION, THE HAND PIECE INTERMITTENTLY TURNED OFF AND ON. TWO HANDPIECES WERE TRIED AND EITHER WOULD WORK CONTINUOUSLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLASMABLADE TISSUE DISSECTION DEVICE | GEI | MEDTORNIC ADVANCED ENERGY LLC | PLASMABLADE 3.0S | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | PULSAR GENERATOR |