FDA Adverse Event
Malfunction
Summary report: N
GREENLIGHT MOXY
MDR report key: 2121891
·
Received May 23, 2011
Report
- Report Number
- 2937094-2011-01066
- Event Type
- Malfunction
- Date Received
- May 23, 2011
- Date of Event
- December 2, 2010
- Report Date
- December 28, 2010
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
- Product Code
- GEX
- PMA / PMN Number
- K100746
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INFORMATION INDICATING THAT AN MDR WAS REQUIRED REGARDING THIS COMPLAINT WAS RECEIVED ON (B)(6) 2011.
Description of Event or Problem · 1
IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2010, THE FIBER TIP FELL OFF; THE FIBER NEVER FIRED AT 0 JOULES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GREENLIGHT MOXY | SURGICAL FIBER | GEX | AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY | NA | 045A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |