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

Model Number	CF-HQ1100DI
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that the colonovideoscope tested positive for an unexpected contamination.The issue was found during a routine culture of the scope.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the results of third-party testing, the device evaluation and the final investigation.Following field was update: d8, g3, h2, h3, h4, h6, h11.The user facility provided the following result of the culture test, performed at the third-party labs: sampling date: (b)(6) 2025.Sampling from: sampling solution instrument / biopsy / suction channel; sampling solution auxiliary channel; sampling solution air/ water channel; swab distal end.Bacterial identification: micrococcus luteus.The device was returned to olympus for inspection and the reported failure found during investigation was not confirmed.According to the investigation, the device was culture tested positive by the customer; however, the device was tested negative by olympus, therefore the user request is not confirmed.The root cause could not be identified.Based on the results of the investigation, the most probable cause of the reported issue of contamination traced to user, which indicates that the reported issue caused partially or wholly by the user of the device including sample handling.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.

• 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 ; 5082077661
• MDR Report Key: 20865736
• Report Number: 9610595-2024-40401
• Device Sequence Number: 12935136
• Product Code: FDF
• UDI-Device Identifier: 04953170424298
• UDI-Public: 04953170424298
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K222584
• 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
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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-HQ1100DI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2022
• 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