FDA Adverse Event
Malfunction
Summary report: N
GREENLIGHT XPS LASER SYSTEM
MDR report key: 2093242
·
Received May 3, 2011
Report
- Report Number
- 2937094-2011-00941
- Event Type
- Malfunction
- Date Received
- May 3, 2011
- Date of Event
- March 31, 2011
- Report Date
- March 31, 2011
- Manufacturer
- AMS, INNOVATION CENTER - SILICON VALLEY
- Product Code
- GEX
- PMA / PMN Number
- K092735
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFO REGARDING THIS COMPLAINT WAS RECEIVED ON (B)(4) 2011, WHICH INDICATED THAT AN MDR WAS REQUIRED.
Description of Event or Problem · 1
IT WAS REPORTED ON (B)(6) 2011, DURING THE PROCEDURE, ERROR MESSAGE 172 OCCURRED. PER THE CUSTOMER, THE PROCEDURE WAS CANCELLED. 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 |