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

Model Number	CF-HQ190L
Medical Device Problem Codes	Contamination (1120); No Display/Image (1183); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the colonovideoscope displayed no video output during a diagnostic colonoscopy while the patient was sedated and the device was in use.Upon connection, the image would briefly appear before the image shut off.The procedure was completed using the same device.During the initial evaluation of the device, it was observed there was an error code e216.In addition, it was also noted there was white residue inside the air / water (a/w) channel and inside the auxiliary water flow.No patient harm was reported.
Additional Manufacturer Narrative
The final investigation has been completed.The device was returned to olympus for inspection, and the reported failure along with the initial evaluation findings were confirmed.A root cause could not be identified.Based on the results of the investigation, it is likely that the reported no-image condition, along with the initial evaluation finding of error code e216, was caused by an expected or random component failure without any design or manufacturing issue.The cause of the initial evaluation findings of white residue in the air/water channel and auxiliary channel could not be determined.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor the field performance of 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: 50948165
• Report Number: 9610595-2026-80575
• Device Sequence Number: 10446685
• Product Code: FDF
• UDI-Device Identifier: 04953170305115
• UDI-Public: 04953170305115
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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-HQ190L
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2015
• 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