inforMED
MalfunctionFDF

EVIS EXERA III COLONOVIDEOSCOPE

Received Jul 30, 2026 · Event occurred Jul 13, 2026

Report 9610595-2026-61298 · MDR key 50081058

Device

Generic name

Colonovideoscope

Model number

CF-HQ190L

Product problems

  • Poor Quality Image

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

The customer reported a static image issue during inspection for use involving an Olympus Colonovideoscope. There was no patient injury reported.

Additional Manufacturer Narrative

The device was returned to Olympus for evaluation, and the customer allegation was confirmed.In addition, the following reportable malfunctions were identified during the device evaluation: scattered image.Based on the results of the investigation, the most probable cause of the image issues was a bad printed circuit board.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.