FDA Adverse Event
Malfunction
Summary report: N
G-PROBE
MDR report key: 1870278
·
Received October 7, 2010
Report
- Report Number
- 1870278
- Event Type
- Malfunction
- Date Received
- October 7, 2010
- Date of Event
- September 23, 2010
- Report Date
- October 7, 2010
- Manufacturer
- IRIDEX
- Product Code
- HQF
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MO, US
Narratives
Description of Event or Problem · 1
LASER WOULD NOT RECOGNIZE PROBE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | G-PROBE | LASER PROBE | HQF | IRIDEX | 11256-1 | 013689 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 93 YR |