FDA Adverse Event
Malfunction
Summary report: N
GREENLIGHT HPS BPH FIBER OPTIC
MDR report key: 3162508
·
Received June 6, 2013
Report
- Report Number
- 2937094-2013-00655
- Event Type
- Malfunction
- Date Received
- June 6, 2013
- Date of Event
- May 8, 2012
- Report Date
- May 15, 2013
- Manufacturer
- AMERICAN MEDICAL SYSTEMS
- Product Code
- GEX
- PMA / PMN Number
- K062719
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4) REFERS TO FORWARD-FIRING OF THE SIDE-FIRING SURGICAL FIBER; A CODE REQUEST HAS BEEN SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE USING THE SIDE-FIRING SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE FIBER WAS OBSERVED TO FIRE STRAIGHT RATHER THAN DOWN (FORWARD-FIRING). NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 251772 | GREENLIGHT HPS BPH FIBER OPTIC | POWERED SURGICAL LASER INSTRUMENT | GEX | AMERICAN MEDICAL SYSTEMS | 10-2090 | 302H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |