FDA Adverse Event
Malfunction
Summary report: N
PLASMABLADE TISSUE DISSECTION DEVICE
MDR report key: 2822352
·
Received October 25, 2012
Report
- Report Number
- 3007069406-2012-00397
- Event Type
- Malfunction
- Date Received
- October 25, 2012
- Date of Event
- February 8, 2011
- Report Date
- February 8, 2011
- Manufacturer
- MEDTRONIC ADVANCED ENERGY LLC
- Product Code
- GEI
- PMA / PMN Number
- K082709
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MANUFACTURER FOR THE TIME PERIOD (B)(4) 2010 THROUGH (B)(4) 2012. THE DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE LOT HISTORY WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNKNOWN.
Description of Event or Problem · 1
IT WAS REPORTED THE DOCTOR GAVE FEEDBACK THAT "A COUPLE BLADES THAT HAVE SHORTED OUT, HE THINKS IT IS BECAUSE HE IS NOT USING THE SUCTION".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLASMABLADE TISSUE DISSECTION DEVICE | GEI | MEDTRONIC ADVANCED ENERGY LLC | PLASMABLADE PLUS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | PULSAR GENERATOR |