FDA Adverse Event
Malfunction
Summary report: N
GREENLIGHT XPS LASER SYSTEM
MDR report key: 2073653
·
Received April 13, 2011
Report
- Report Number
- 2937094-2011-00641
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- March 3, 2011
- Report Date
- March 3, 2011
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
- Product Code
- GEX
- PMA / PMN Number
- K092735
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION REGARDING THIS COMPLAINT WAS RECEIVED ON (B)(6) 2011 WHICH INDICATED THAT AN MDR WAS REQUIRED.
Description of Event or Problem · 1
IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011 DURING THE PROCEDURE THE LASER SYSTEM HAD A FIBER CARD ERROR READING. ALSO, IT WAS REPORTED BY THE CUSTOMER TWO FIBERS/FIBER CARDS WERE USED. PER THE CUSTOMER, THE LASER SYSTEM WAS RE-BOOTED AND CYCLED. ALSO, THE CUSTOMER REPORTED THE ERROR MESSAGE COULD NOT BE CLEARED. PER THE CUSTOMER, THE FIBERS USED WERE FROM THE SAME LOT NUMBER (0010-2400-106A). ALSO, THE CUSTOMER REPORTED THE ERROR MESSAGE WAS CLEARED WHEN FIBERS FROM ANOTHER LOT NUMBER WERE USED. THE PROCEDURE WAS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GREENLIGHT XPS LASER SYSTEM | LASER SURGICAL INSTRUMENT | GEX | AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY | 0010-0210 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |