FDA Adverse Event
Injury
Summary report: N
GREENLIGHT MOXY FIBER OPTIC
MDR report key: 2800946
·
Received October 18, 2012
Report
- Report Number
- 2937094-2012-01083
- Event Type
- Injury
- Date Received
- October 18, 2012
- Date of Event
- September 25, 2012
- Report Date
- September 25, 2012
- Manufacturer
- AMERICAN MEDICAL SYSTEMS
- Product Code
- GEX
- PMA / PMN Number
- K100746
- Adverse Event
- Yes
- 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 THE FIBER CAP DETACHED INSIDE OF THE PT AT 149,325 JOULES INTO THE CASE. THE FIBER CAP WAS RETRIEVED. METHOD OF REMOVAL IS UNK. THERE WAS NO INDICATION OR REPORT OF ANY PART OF THE DEVICE REMAINING INSIDE THE PT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THERE WAS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GREENLIGHT MOXY FIBER OPTIC | POWERED LASER SURGICAL INSTRUMETN | GEX | AMERICAN MEDICAL SYSTEMS | 0010-2400 | 231A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | GREENLIGHT XPS SURGICAL LASER SYSTEM| ACCESSORIES |