FDA Adverse Event
Malfunction
Summary report: N
GREENLIGHT HPS LASER SYSTEM
MDR report key: 2891334
·
Received December 21, 2012
Report
- Report Number
- 2937094-2012-01345
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- January 1, 2012
- Report Date
- November 21, 2012
- Manufacturer
- AMERICAN MEDICAL SYSTEMS
- Product Code
- GEX
- PMA / PMN Number
- K062719
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER'S DESIGNATED SERVICE TECH WAS DISPATCHED TO THE FACILITY TO EVALUATE THE LASER SYSTEM. THE SERVICE TECH DETERMINED THAT THE ROOT CAUSE OF THE ERROR WAS DUE TO A MALFUNCTIONING LASER COMPONENT WHICH WAS REMOVED AND REPLACED. THE SERVICE WAS COMPLETED AND THE LASER WAS RELEASED TO THE CUSTOMER FOR USE.
Description of Event or Problem · 1
IT WAS REPORTED IN THE MIDDLE OF A PROCEDURE AN ERROR CODE 171 (UNDER POWER) WAS DISPLAYED. NO HARM TO PATIENT/USER. NO FURTHER INFORMATION WAS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GREENLIGHT HPS LASER SYSTEM | POWERED LASER SURGICAL INSTRUMENT | GEX | AMERICAN MEDICAL SYSTEMS | 0010-0070 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GREENLIGHT HPS LASER SYSTEM| ACCESSORIES |