MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III COLONOVIDEOSCOPE

Model Number	CF-HQ190L
Medical Device Problem Codes	Erratic or Intermittent Display (1182); No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the colonovideoscope to the service center for evaluation related to a separate issue.During inspection, the service repair technician identified that the device had displayed no image and a black screen occurs intermittently.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, it is likely the following led to the malfunction: due to damage connector block and component failure.Three attempts were performed to obtain additional information, but no response was received from the customer.Date of event is unknown.Additional information will be provided if available.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 III COLONOVIDEOSCOPE
• Common Device Name: COLONOVIDEOSCOPE
• 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: 50524642
• Report Number: 9610595-2026-71091
• Device Sequence Number: 6012463
• Product Code: FDF
• UDI-Device Identifier: 04953170436574
• UDI-Public: 04953170436574
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K131780
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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: Other
• Device Model Number: CF-HQ190L
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/13/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown