FDA Adverse Event
Malfunction
Summary report: N
PLASMABLADE TISSUE DISSECTION DEVICE
MDR report key: 2822312
·
Received October 25, 2012
Report
- Report Number
- 3007069406-2012-00432
- Event Type
- Malfunction
- Date Received
- October 25, 2012
- Report Date
- August 25, 2011
- Manufacturer
- MEDTRONIC ADVANCED ENERGY LLC
- Product Code
- GEI
- PMA / PMN Number
- K083415
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 MANUFACTURER FOR THE TIME PERIOD (B)(6) 2012. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THE TIP REMAINED INTACT WITH SLIGHT MELT BACK OF THE CLEAR HOUSING NEAR THE CORNER OF THE ELECTRODE WIRE. REVIEW OF THE LOT HISTORY REVEALED NO ANOMALIES. END OF REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THE ADENOID BLADE BROKE. IT MAY HAVE BEEN DUE TO SCRUB TECH CLEANING. THERE WERE NO PATIENT CONSEQUENCES. THIRD OF 3 EVENTS; SEE 3007069406-2012-00460 AND 3007069406-2012-00431.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLASMABLADE TISSUE DISSECTION DEVICE | GEI | MEDTRONIC ADVANCED ENERGY LLC | PLASMABLADE TNA | 46645 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | PULSAR GENERATOR |