FDA Adverse Event
Malfunction
Summary report: N
GREENLIGHT HPS BPH FIBER OPTIC
MDR report key: 2844305
·
Received November 8, 2012
Report
- Report Number
- 2937094-2012-01222
- Event Type
- Malfunction
- Date Received
- November 8, 2012
- Date of Event
- September 21, 2012
- Report Date
- October 11, 2012
- Manufacturer
- AMERICAN MEDICAL SYSTEMS
- Product Code
- GEX
- PMA / PMN Number
- K062719
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4) REFERS TO FORWARD-FIRING OF THE SIDE-FIRING SURGICAL FIBER.
Description of Event or Problem · 1
IT WAS REPORTED DURING A PROSTATE PROCEDURE, THE SIDE-FIRING FIBER WAS NOTICED TO HAVE COMMENCED FORWARD FIRING AT 242861 JOULES. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. NO PATIENT OR END USER INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GREENLIGHT HPS BPH FIBER OPTIC | POWERED LASER SURGICAL SYSTEMS | GEX | AMERICAN MEDICAL SYSTEMS | 0010-2090 | 204H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | ACCESSSORIES| GREENLIGHT HPS SURGICAL LASER SYSTEM |