FDA Adverse Event
Malfunction
Summary report: N
GREENLIGHT HPS LASER SYSTEM
MDR report key: 1981497
·
Received January 31, 2011
Report
- Report Number
- 2937094-2011-00002
- Event Type
- Malfunction
- Date Received
- January 31, 2011
- Date of Event
- January 4, 2011
- Report Date
- January 4, 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
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE CUSTOMER ON (B)(6) 2011 THAT DURING THE PROCEDURE THE CUSTOMER EXPERIENCED AN ERROR CODE 173 (PD MISMATCH ERROR) FROM THE LASER SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GREENLIGHT HPS LASER SYSTEM | LASER SURGICAL INSTRUMENT | GEX | AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY | 0010-0070 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |