FDA Adverse Event
Injury
Summary report: N
GREENLIGHT XPS LASER SYSTEM
MDR report key: 6193093
·
Received December 21, 2016
Report
- Report Number
- 2937094-2016-01248
- Event Type
- Injury
- Date Received
- December 21, 2016
- Report Date
- December 19, 2016
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
- Product Code
- GEX
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CONSOLE WAS EVALUATED AND REPAIRED IN THE FIELD ON (B)(6) 2016. ERROR 213, 235, 302.13 AND 202.11 WERE OBSERVED. THE LASER POWER SUPPLY WAS REPLACED. NO FURTHER ERRORS WERE OBSERVED. THE SYSTEM WAS TESTED AND VERIFIED TO MEET MANUFACTURER'S SPECIFICATIONS.
Additional Manufacturer Narrative · 1
SERVICE REPAIR IN THE FIELD WAS PERFORMED ON (B)(6) 2016. THE REPLACED LPS S/N (B)(4) WAS RECEIVED AT THE MANUFACTURER ON JANUARY 03, 2017. IT WAS NOTED THAT THE LPS WAS DISCARDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING PREPARATION OF A BHP PROCEDURE "ERROR 202" WAS OBSERVED. THE CONSOLE COULD NOT BE USED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE PROCEDURE (TURP). NO HARM TO THE PATIENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 842572 | GREENLIGHT XPS LASER SYSTEM | POWERED LASER SURGICAL INSTRUMENT | GEX | AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) | 0010-0210 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |