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

Model Number	CF-H170I
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updated fields: h2, h6, and h11.Based on the results of the final investigation of the device the initial evaluation finding was confirmed.The most likely cause of the reportable malfunction identified during initial device evaluation was traced to component failure.Olympus will continue to monitor the field performance for this device.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
The customer returned the colonovideoscope for a separate issue.During the initial evaluation of the returned device, a scope communication error (b31) was observed.No patient involvement.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
The investigation is still ongoing.\ \ a supplemental report will be submitted when the investigation has been completed or when new and significant information becomes available.\ \ olympus will continue to monitor the field performance of this device.

• 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: 50910701
• Report Number: 9610595-2026-79517
• Device Sequence Number: 5330268
• Product Code: FDF
• UDI-Device Identifier: 04953170334184
• UDI-Public: 04953170334184
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112680
• 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): 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: Other
• Device Model Number: CF-H170I
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/01/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/28/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown