FDA Adverse Event
Other
Summary report: N
PLASMABLADE TISSUE DISSECTION DEVICE
MDR report key: 2640499
·
Received June 25, 2012
Report
- Report Number
- 3007069406-2012-00114
- Event Type
- Other
- Date Received
- June 25, 2012
- Date of Event
- April 12, 2012
- Report Date
- April 12, 2012
- Manufacturer
- MEDTRONIC ADVANCED ENERGY LLC
- Product Code
- GEI
- PMA / PMN Number
- K083415
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT WAS NOT AVAILABLE FOR EVALUATION BECAUSE THE DEVICE HAD BEEN DISCARDED. A REVIEW OF THE LHR DID NOT REVEAL ANY ISSUES DURING THE MFG OF THIS LOT.
Description of Event or Problem · 1
THE MEDTECH REPORTED WHEN THE PACKAGE WAS OPENED IT WAS NOTED THAT THE TONSIL TIP WS DEFECTIVE/CONTAMINATED. THERE WAS NO REPORTS OF INJURY TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLASMABLADE TISSUE DISSECTION DEVICE | GEI | MEDTRONIC ADVANCED ENERGY LLC | PLASMABLADE TNA | 53142 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NOT AVAILABLE |