FDA Adverse Event
Injury
Summary report: N
ANGLED DELIVERY DEVICE, GREENLIGHT XPS
MDR report key: 2431040
·
Received January 26, 2012
Report
- Report Number
- 2937094-2012-00118
- Event Type
- Injury
- Date Received
- January 26, 2012
- Date of Event
- September 30, 2011
- Report Date
- November 3, 2011
- Manufacturer
- AMS INNOVATIVE CENTER-SAN JOSE
- Product Code
- GEX
- PMA / PMN Number
- K100746
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE FIBER SERIAL NUMBER WAS UNK.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE FIBER CAP WAS LOOSE AND BROKE OFF INSIDE THE PT AT 10, 000 JOULES INTO THE CASE. THROUGH FOLLOW-UP WITH THE PHYSICIAN, ALTHOUGH THE METHOD OF FIBER CAP RETRIEVAL WAS NOT REPORTED, IT WAS CONFIRMED THAT THE FIBER CAP WAS RETRIEVED EASILY WITHOUT ANY RISK TO THE PT. THE CASE WAS COMPLETED WITH A SECOND FIBER. THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANGLED DELIVERY DEVICE, GREENLIGHT XPS | SURGICAL FIBER | GEX | AMS INNOVATIVE CENTER-SAN JOSE | 0010-2400 | 128A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | AND ACCESSORIES| GREENLIGHT XPS SURGICAL LASER SYSTEM |