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

Model Number	CF-EZ1500DL
Medical Device Problem Codes	No Display/Image (1183); Communication or Transmission Problem (2896); Output Problem (3005)
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
The customer reported no light, no image and error communicated code e227 during inspection for use involving an olympus colonovideoscope.There were no reports of patient involvement.
Additional Manufacturer Narrative
The final investigation has been completed.The failure reported by the customer is not confirmed.The cause was not determined.Olympus will continue to monitor the field performance of this device and evaluate any additional information received through post-market surveillance activities.

• Brand Name: 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: 50334984
• Report Number: 9610595-2026-67670
• Device Sequence Number: 5839801
• Product Code: FDF
• UDI-Device Identifier: 04953170425158
• UDI-Public: 04953170425158
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K250432
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/19/2026

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-EZ1500DL
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/04/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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