FDA Adverse Event
Malfunction
Summary report: N
OLYMPUS
MDR report key: 375551
·
Received February 1, 2002
Report
- Report Number
- 8010047-2002-00002
- Event Type
- Malfunction
- Date Received
- February 1, 2002
- Report Date
- January 4, 2002
- Manufacturer
- THE OLYMPUS OPTICAL CO., LTD.
- Product Code
- FDF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
A HOSPITAL NURSE MANAGER REPORTED THAT A VIDEO IMAGE FROZE DURING A COLONOSCOPY PROCEDURE. THE CASE WAS COMPLETED WITH A SECOND INSTRUMENT AND THERE WERE NO COMPLICATIONS ASSOCIATED WITH THE OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OLYMPUS | COLONOVIDEOSCOPE | FDF | THE OLYMPUS OPTICAL CO., LTD. | CF-140L | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |