FDA Adverse Event
Other
Summary report: N
PLASMABLADE TISSUE DISSECTION DEVICE
MDR report key: 2549045
·
Received April 18, 2012
Report
- Report Number
- 3007069406-2012-00087
- Event Type
- Other
- Date Received
- April 18, 2012
- Report Date
- March 20, 2012
- Manufacturer
- MEDTRONIC ADVANCED ENERGY LLC
- Product Code
- GEI
- PMA / PMN Number
- K083415
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. INSPECTION OF THE LOT HISTORY RECORD DID NOT NOTE ANY ANOMALIES DURING THE MFG OF THE LOT. THE PHYSICIAN REATTACHED THE TIP AND COMPLETED THE PROCEDURE. THERE WAS NO HARM TO THE PT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TONSIL TIP FELL OFF DURING A T AND A PROCEDURE; THE TIP HAD NOT BEEN SEATED PROPERLY TO THE INDICATOR LINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLASMABLADE TISSUE DISSECTION DEVICE | GEI | MEDTRONIC ADVANCED ENERGY LLC | PLASMABLADE TNA | 52726 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | NOT AVAILABLE |