FDA Adverse Event
Other
Summary report: N
TALON ELECTROSURGICAL DEVICE
MDR report key: 1215632
·
Received October 20, 2008
Report
- Report Number
- 1056436-2008-00052
- Event Type
- Other
- Date Received
- October 20, 2008
- Date of Event
- February 5, 2008
- Report Date
- October 15, 2008
- Manufacturer
- ANGIODYNAMICS, INC.
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT WAS CONFIRMED. HOWEVER, THE CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. ANGIODYNAMICS IFU STATES THE WARNING, "DO NOT ATTACH ANYTHING (I.E., CLAMPS, ET.) TO THE DEVICE. THIS MAY DAMAGE THE INSULATION WHICH COULD CONTRIBUTE TO PATIENT INJURY."
Description of Event or Problem · 1
IT APPEARS THAT THE THERMAL COATING IS COMING OFF THE DISTAL END OF THE PROBE. DEVICE WORKED FINE, BUT SURGEON WAS CONCERNED ABOUT BURN AREA SO ANOTHER DEVICE WAS OPENED AND USED. DEVICE DID NOT FAIL, WAS USED FOR TWO ABLATIONS PRIOR TO NOTICING THAT COATING WAS COMING OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TALON ELECTROSURGICAL DEVICE | ELECTROSURGICAL DEVICE | GEI | ANGIODYNAMICS, INC. | NA | 940183 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |