FDA Adverse Event
Malfunction
Summary report: N
GREENLIGHT ADDSTAT
MDR report key: 2062278
·
Received April 12, 2011
Report
- Report Number
- 2937094-2011-00614
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- January 12, 2011
- Report Date
- March 15, 2011
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
- Product Code
- GEX
- PMA / PMN Number
- K062719
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011, THE AIMING BEAM FIRED STRAIGHT OUT OF THE FIBER AT 124,331 JOULES. NO PT INJURY WAS REPORTED.
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 | 031H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |