FDA Adverse Event
Other
Summary report: N
OLYMPUS
MDR report key: 470219
·
Received June 10, 2003
Report
- Report Number
- 470219
- Event Type
- Other
- Date Received
- June 10, 2003
- Date of Event
- October 28, 2002
- Report Date
- June 10, 2003
- Manufacturer
- OLYMPUS
- Product Code
- FTJ
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
OLYMPUS CFQ 160 AL VIDEO COLONOSCOPE WAS NOT PROPERLY CLEANED AND STERILIZED ACCORDING TO MFR INSTRUCTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OLYMPUS | COLONOSCOPE | FTJ | OLYMPUS | CF160 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other |