FDA Adverse Event
Injury
Summary report: N
GREENLIGHT HPS LASER SYSTEM
MDR report key: 3213339
·
Received July 3, 2013
Report
- Report Number
- 2937094-2013-00724
- Event Type
- Injury
- Date Received
- July 3, 2013
- Report Date
- June 11, 2013
- Manufacturer
- AMERICAN MEDICAL SYSTEMS
- Product Code
- GEX
- PMA / PMN Number
- K062719
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED AN ERROR WITH THEIR LASER SYSTEM. IT WAS REPORTED THAT DUE TO THIS ERROR THE CASE WAS COMPLETED WITH A TURP. THE OUTCOME WAS REPORTED AS "NO DAMAGES TO THE PT".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303509 | GREENLIGHT HPS LASER SYSTEM | POWERED SURGICAL LASER INSTRUMENT | GEX | AMERICAN MEDICAL SYSTEMS | 0010-0075 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |