FDA Adverse Event
Injury
Summary report: N
MODEL 600R
MDR report key: 1316600
·
Received February 18, 2009
Report
- Report Number
- 2951571-2009-00001
- Event Type
- Injury
- Date Received
- February 18, 2009
- Date of Event
- January 13, 2009
- Report Date
- February 12, 2009
- Manufacturer
- NEW STAR LASERS, INC.
- Product Code
- GEX
- PMA / PMN Number
- K040921
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
FIBER OPTIC USED TO DELIVER THE LASER ENERGY TO THE TREATMENT SITE BROKE INSIDE THE PATIENT WHILE BEING PULLED OUT. PROCEDURE BEING PERFORMED AT THE TIME WAS FOR REFLUX OF THE GREAT SAPHENOUS VEIN (GSV). PHYSICIAN PERFORMED A CUTDOWN AND RETRIEVED FIBER. PATIENT WAS PLACED ON ANTIBIOTICS AS A PRECAUTIONARY MEASURE. NO SUBSEQUENT PROBLEMS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MODEL 600R | FIBER OPTIC DELIVERY SYSTEM | GEX | NEW STAR LASERS, INC. | 600R | 9421A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |