FDA Adverse Event
Malfunction
Summary report: N
SLIM LINE EZ 550
MDR report key: 1549113
·
Received November 25, 2009
Report
- Report Number
- 1549113
- Event Type
- Malfunction
- Date Received
- November 25, 2009
- Date of Event
- November 18, 2009
- Report Date
- November 25, 2009
- Manufacturer
- LUMENIS, INC.
- Product Code
- GEX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
Narratives
Description of Event or Problem · 1
THE DOCTOR WAS UNABLE TO PASS THE FIBER THROUGH THE GI SCOPE AND WHEN IT CAME OUT OF THE SCOPE, THE LIGHT WAS NOT VISIBLE. WHEN THE STAFF REMOVED THE FIBER, IT WAS NOTED THE TIP FRACTURED ABOUT 1/2 ABOVE THE END.
Description of Event or Problem · 1
THE DOCTOR WAS UNABLE TO PASS THE FIBER THROUGH THE GI SCOPE AND WHEN IT CAME OUT OF THE SCOPE, THE LIGHT WAS NOT VISIBLE. WHEN THE STAFF REMOVED THE FIBER, IT WAS NOTED THE TIP FRACTURED ABOUT 1/2 ABOVE THE END.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SLIM LINE EZ 550 | LASER FIBER | GEX | LUMENIS, INC. | * | 85850209 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |