inforMED
MalfunctionFDF

EVIS EXERA III COLONOVIDEOSCOPE

Received Jul 31, 2026 · Event occurred Jul 2, 2026

Report 9610595-2026-62130 · MDR key 50107632

Device

Generic name

Colonovideoscope

Model number

PCF-H190DL

Product problems

  • Degraded

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

The customer returned the colonovideoscope to the service center for evaluation related to a separate issue. During testing the repair center technician found auxiliary water inlet has corrosion cause trace to component failure. There was no patient involvement.

Additional Manufacturer Narrative

The device was returned to Olympus for inspection.A root cause could not be identified. Based on the results of the investigation, the most probable cause of the complaint is cause traced to component failure.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.