FDA Adverse Event
Injury
Summary report: N
GREENLIGHT HPS BPH FIBER OPTIC
MDR report key: 3852309
·
Received June 5, 2014
Report
- Report Number
- 2937094-2014-00452
- Event Type
- Injury
- Date Received
- June 5, 2014
- Date of Event
- April 2, 2014
- Report Date
- May 27, 2014
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
- Product Code
- GEX
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS ISSUE HAS BEEN FOUND TO HAVE BEEN PREVIOUSLY REPORTED UNDER MDR # 2937094-2014-00493, SUBMITTED ON 06/13/2014. ALL FUTURE REFERENCE AND CORRESPONDENCE WILL BE UNDER MDR # 2937094-2014-00493.
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE CUSTOMER REPORTED "FIBER BURNOUT". FROM THE DESCRIPTION IT APPEARS THAT THE FIBER WAS EMITTING ENERGY AT A DECREASED LEVEL AND THEREFORE NO LONGER VAPORIZING EFFICIENTLY. THE FIBER WAS EXCHANGED AND THE SECOND FIBER WAS NOTED AS HAVING THE SAME ISSUE (¿BURNED OUT") DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE PROCEDURE (TURP). THERE WAS NO REPORT OF HARM TO THE PATIENT. THIS REPORT IS FOR THE SECOND FIBER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 328741 | GREENLIGHT HPS BPH FIBER OPTIC | POWERED LASER SURGICAL INSTRUMENT | GEX | AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) | 0010-2090 | 320H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |