FDA Adverse Event
Malfunction
Summary report: N
GREENLIGHT ADDSTAT
MDR report key: 2092963
·
Received May 5, 2011
Report
- Report Number
- 2937094-2011-00968
- Event Type
- Malfunction
- Date Received
- May 5, 2011
- Date of Event
- December 14, 2010
- Report Date
- April 19, 2011
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
- Product Code
- GEX
- PMA / PMN Number
- K062719
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2010 THE FIBER FORWARD FIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GREENLIGHT ADDSTAT | SURGICAL FIBER | GEX | AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY | NA | 031M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |