FDA Adverse Event
Malfunction
Summary report: N
MWA PERCUTANEOUS ANTENNA 17CM
MDR report key: 2221488
·
Received August 17, 2011
Report
- Report Number
- 1717344-2011-00691
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- August 4, 2011
- Report Date
- August 4, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- NEY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN REC'D FOR EVAL. IF THE SAMPLE IS REC'D OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AFTER A LIVER ABLATION, PLASTIC COATING ON THE ANTENNA WAS DELAMINATED. ANOTHER ANTENNA WAS UTILIZED BY THE SURGEON TO COMPLETE THE PROCEDURE WITH NO FURTHER DIFFICULTIES. THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MWA PERCUTANEOUS ANTENNA 17CM | MICROWAVE ABLATION ACCESSORY | NEY | COVIDIEN LP (VALLEYLAB) | 157521 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |