FDA Adverse Event
Other
Summary report: N
STARBURST TALON SEMI-FLEX
MDR report key: 1611841
·
Received February 16, 2010
Report
- Report Number
- 1056436-2010-00009
- Event Type
- Other
- Date Received
- February 16, 2010
- Date of Event
- February 5, 2010
- Report Date
- February 16, 2010
- Manufacturer
- ANGIODYNAMICS
- Product Code
- GEI
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PHYSICIAN PLACED TALON IN PATIENT, LESION FELT HARD INITIALLY WHEN PLACING THE PROBE. HE EXTENDED THE TINES THEN TOOK A SCAN TO SEE IF HE HAD GOOD PLACEMENT. THE DOCTOR HAD TO REPOSITION, HE PULLED BACK ON THE TINES BUT SAID IT DIDN'T FEEL RIGHT. HE REMOVED THE PROBE FROM THE PATIENT AND FOUND THAT TWO TINES HAD BEEN LEFT INSIDE THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STARBURST TALON SEMI-FLEX | RFA PROBE | GEI | ANGIODYNAMICS | NA | 983839 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |