FDA Adverse Event
Malfunction
Summary report: N
GREENLIGHT ADDSTAT
MDR report key: 1944157
·
Received December 29, 2010
Report
- Report Number
- 2937094-2010-01471
- Event Type
- Malfunction
- Date Received
- December 29, 2010
- Date of Event
- August 10, 2010
- Report Date
- December 9, 2010
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER- SILICON VALLEY
- Product Code
- GEX
- PMA / PMN Number
- K062719
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THE FIBER END FIRED AT 605 JOULES. NO PATIENT 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 | 009H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |