MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA II COLONOVIDEOSCOPE; Colonoscope And Accessories, Flexible/Rigid

Model Number	CF-H180AI
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updated fields: d8, h2, h6, h11.The device was returned to olympus for inspection, the reported failure and the failure identified during initial evaluation were confirmed.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: damage on switch.The cause is traced to a component failure.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II COLONOVIDEOSCOPE
• Common Device Name: Colonoscope And Accessories, Flexible/Rigid
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; +1(508)207-7661
• MDR Report Key: 50550202
• Report Number: 9610595-2026-71732
• Device Sequence Number: 16101373
• Product Code: FDF
• UDI-Device Identifier: 04953170339585
• UDI-Public: 04953170339585
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CF-H180AI
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/14/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/11/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown