FDA Adverse Event
Other
Summary report: N
TALON ELECTROSURGICAL DEVICE, 15 CM
MDR report key: 1011972
·
Received March 10, 2008
Report
- Report Number
- 1056436-2008-00012
- Event Type
- Other
- Date Received
- March 10, 2008
- Date of Event
- March 5, 2007
- Report Date
- March 10, 2008
- Manufacturer
- ANGIODYNAMICS, INC.
- Product Code
- GEI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE 5TH OF MARCH PERFORMED WAS A PERCUTANEOUS RADIOFREQUENCY OF AN HCC ON CIRRHOTIC LIVER; FOLLOWING THE FIRST ABLATION (THE LESION WAS QUITE BIG) CONTROLLED THE DEVICE BEFORE INSERTING IT FOR SECOND ABLATION AND NOTED THAT THE ARRAYS WERE SHORTER THAN USUAL; IN ADDITION, SAW THERMOCOUPLE WIRES HANGING FROM THREE OF THESE ARRAYS. BY TC CONTROL, COULD ENSURE THREE ARRAYS TIPS HAD BEEN LEFT IN THE PT'S LIVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TALON ELECTROSURGICAL DEVICE, 15 CM | ELECTROSURGICAL DEVICE | GEI | ANGIODYNAMICS, INC. | NA | 30299 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |