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

Model Number	CF-H180AI
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during reprocessing, the colonovideoscope tested positive for: on (b)(6) 2025, all channels sampled, 13 colony forming units (cfus) of escherichia hermanii.On (b)(6) 2025 (control), all channels sampled, 15 colony forming units (cfus) of acinetobacter baumannii, escherichia hermanii, methylobacterium species, and micrococucus luleus.On (b)(6) 2025 (recheck), all channels sampled, 2 colony forming units (cfus) of dermacoccus sp.On (b)(6) 2025 (recheck), all channels sampled, 20 colony forming units (cfus) of micrococci spp, coagulase-negative staphylococci, staphylococcus saprophyticus, acinetobacter baumannii, dermacoccus sp, and priestia sp.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 investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.

• Brand Name: EVIS EXERA II 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: 23959813
• Report Number: 9610595-2026-00968
• Device Sequence Number: 5740010
• Product Code: FDF
• UDI-Device Identifier: 04953170339585
• UDI-Public: 04953170339585
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

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-H180AI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown