FDA Adverse Event
Malfunction
Summary report: N
GREENLIGHT MOXY FIBER OPTIC
MDR report key: 3883049
·
Received June 19, 2014
Report
- Report Number
- 2937094-2014-00522
- Event Type
- Malfunction
- Date Received
- June 19, 2014
- Date of Event
- June 11, 2014
- Report Date
- June 12, 2014
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
- Product Code
- GEX
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE THE FIRST FIBER BECAME END FIRING @ 29,028 JOULES 6:27 MINUTES. THE FIBER WAS EXCHANGED AND THE SECOND FIBER ALSO EXHIBITED END FIRING. IT WAS NOTED BY THE INITIAL REPORTER THAT THIS ISSUE(S) OCCURRED DUE TO PROSTATIC CALCIFICATIONS (STONES). THE PROCEDURE WAS COMPLETED WITH A THIRD FIBER. PATIENT OUTCOME: ¿OK¿ REPORTED. THIS REPORT IS FOR THE FIRST FIBER:
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 359995 | GREENLIGHT MOXY FIBER OPTIC | POWERED LASER SURGICAL INSTRUMENT | GEX | AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) | 0010-2400 | 405A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |