FDA Adverse Event
Malfunction
Summary report: N
GREENLIGHT XPS LASER SYSTEM
MDR report key: 2073636
·
Received April 13, 2011
Report
- Report Number
- 2937094-2011-00640
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- March 16, 2011
- Report Date
- March 16, 2011
- Manufacturer
- AMS, INNOVATION CENTER - SILICON VALLEY
- Product Code
- GEX
- PMA / PMN Number
- K092735
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011 DURING THE MIDDLE OF THE PROCEDURE ERROR 172 WAS RECEIVED FROM THE LASER SYSTEM. ALSO, THE CUSTOMER REPORTED ERROR 172 APPEARED AT 120 WATTS. PER THE CUSTOMER, THE LASER SYSTEM WENT TO SAFETY SHUT DOWN. ALSO, THE CUSTOMER REPORTED THE LASER SYSTEM SEEMED TO HAVE BEEN WORKING ALRIGHT AT 80 WATTS. THE CUSTOMER REPORTED THAT THE PROCEDURE WAS COMPLETED. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GREENLIGHT XPS LASER SYSTEM | LASER SURGICAL INSTRUMENT | GEX | AMS, INNOVATION CENTER - SILICON VALLEY | 0010-0210 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |