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

Model Number	CF-HQ1100DL
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject device 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
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the customer provided culture results, results of third-party testing, the device evaluation, and the final investigation.Additional information added to the following fields: b5, h2, h3, h4, h6.Corrected fields: b3, d4 (inadvertently missed), e1 (fax inadvertently missed), g2 (added selection).Olympus provided the following results of the culture test, performed at the third-party labs: sampling date: (b)(6) 2025.Sampling from: distal end surface.Cfu: 1 cfu.Bacterial identification: staphylococcus haemolyticus/ sampling date: (b)(6) 2025, sampling from: air/water channel, cfu: <1 cfu, bacterial identification: n/a.Sampling date: (b)(6) 2025, sampling from: auxiliary channel, cfu: <1 cfu, bacterial identification: n/a.Sampling date: (b)(6) 2025, sampling from: instrument channel, cfu: <1 cfu, bacterial identification: n/a.Sampling date: (b)(6) 2025, sampling from: operating channel, cfu: <1 cfu, bacterial identification: n/a.The device was evaluated where additional potential adverse event(s) were confirmed, white foreign material was noted in the jet tube.Additionally, due to clogging of j-tube in control unit, water cannot be supplied.Based on the results of the investigation, a definitive root cause could not be determined.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with the instructions for use (ifu) before repair, the results conformed to the regulation's recommendation.In regards to the foreign material: based on the results of the investigation, it is likely the result of insufficient reprocessing, however a definitive root cause could not be established.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The subject device tested positive for 215 colony forming units (cfus) of enterobacteria, pseudomonas, and staphylococcus aureus.All channels were sampled.

• 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: 21169733
• Report Number: 9610595-2025-00473
• Device Sequence Number: 4335955
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

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-HQ1100DL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2021
• 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