FDA Adverse Event
Malfunction
Summary report: N
ANGLED DELIVERY DEVICE, GREENLIGHT
MDR report key: 2481043
·
Received March 2, 2012
Report
- Report Number
- 2937094-2012-00210
- Event Type
- Malfunction
- Date Received
- March 2, 2012
- Date of Event
- April 9, 2011
- Report Date
- February 14, 2012
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- GEX
- PMA / PMN Number
- K062719
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SIDE-FIRING FIBER WAS NOTICED TO HAVE COMMENCED FORWARD FIRING AT 28,277 JOULES DURING A PROSTATE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. THE PATIENT WAS REPORTED TO HAVE EXPERIENCED NO PROBLEMS AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANGLED DELIVERY DEVICE, GREENLIGHT | SURGICAL FIBER | GEX | AMERICAN MEDICAL SYSTEMS, INC. | 0010-2090 | 041H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GREENLIGHT SURGICAL LASER SYSTEM| ACCESSORIES |