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

Model Number	CF-Q150L
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the banding in the image was displayed involving an olympus colonovideoscope.There was no patient injury reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.\ \ updated fields include d9, h2, h3, h6, and h11.\ \ the final investigation has been completed.The failure reported by the customer was confirmed.\ \ the most likely cause of the reported issue was traced to slipping in the charge-coupled device (ccd) unit.\ \ should additional relevant information become available, a supplemental report will be submitted.\ \ olympus will continue to monitor the field performance of this device and evaluate any additional information received through post market surveillance activities.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
Date of event is unknown.Additional information will be provided if available.\ \ the investigation is currently ongoing.A supplemental report will be submitted upon completion of the investigation or should new and significant information become available.

• 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: 50917913
• Report Number: 9610595-2026-79772
• Device Sequence Number: 20278251
• Product Code: FDF
• UDI-Device Identifier: 04953170229466
• UDI-Public: 04953170229466
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K001241
• 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
• Report Date (Section B): 09/28/2026

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-Q150L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2015
• 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