FDA Adverse Event
Malfunction
Summary report: N
IRIS RETRACTORS
MDR report key: 1913119
·
Received November 15, 2010
Report
- Report Number
- 1913119
- Event Type
- Malfunction
- Date Received
- November 15, 2010
- Date of Event
- November 2, 2010
- Report Date
- November 15, 2010
- Manufacturer
- SYNERGETICS, INC.
- Product Code
- HNI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
Narratives
Description of Event or Problem · 1
TWO IRIS RETRACTORS BROKE INSIDE THE EYE WHEN THE SURGEON WAS PUTTING IT IN. HE WAS USING THIS TO OPEN THE PUPIL. THE SURGEON STATES HE WAS ABLE TO RETRIEVE ALL THE BROKEN PIECES. THE SURGEON SPOKE WITH THE MANUFACTURER ABOUT THIS PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IRIS RETRACTORS | DISPOSABLE FLEXIBLE IRIS RETRACTOR | HNI | SYNERGETICS, INC. | 40.02-6 | 9010411 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |