MalfunctionFAM
OLYMPUS
Received Dec 9, 2004
Report 8010047-2004-10054 · MDR key 793968
Device
Generic name
Sigmoidovideoscope
Manufacturer
Olympus Optical Co., Ltd.Model number
CF-Q160SCatalog number
NA
Lot number
NA
Product problems
- Image Display Error/Artifact
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE HOSPITAL REPORTED THEY EXPERIENCED A TOTAL LOSS OF IMAGE DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER SIMILAR DEVICE. THERE WAS NO ALLEGATION OF HARM.
Additional Manufacturer Narrative
THE DEVICE IN QUESTION WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION REVEALED EVIDENCE OF FLUID INVASION IN THE ELECTRICAL CONNECTOR AND BODY CONTROL UNIT WHICH MOST LIKELY CAUSED THE USER'S EXPERIENCE. OLYMPUS ATTRIBUTED THESE PHENOMENONS TO IMPROPER REPROCESSING OF THE DEVICE.