MalfunctionFAM
OLYMPUS
Received Jul 14, 2005
Report 8010047-2005-00072 · MDR key 624518
Device
Generic name
Sigmoidovideoscope
Manufacturer
Olympus Optical Co., Ltd.Model number
CF-Q160SCatalog number
NA
Lot number
NA
Product problems
- Blank screen
- Replace
- Device Displays Incorrect Message
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE HOSPITAL REPORTED THEY WERE EXPERIENCING INTERMITTENT YELLOW LINES IN THE IMAGE UNTIL IT BLACKED-OUT COMPLETELY. THE IMAGE WAS UNABLE TO BE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER SIMILAR ENDOSCOPE. THERE WAS NO ALLEGATION OF HARM.