MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE; SMALL INTESTINAL VIDEOSCOPE

Model Number	SIF-Q180
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
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, during reprocessing, the small intestinal videoscope tested positive for klebsiella pneumoniae ss.Pneumoniae.The device was retested on (b)(6) 2025, and it tested positive for klebsiella pneumoniae ss.Pneumoniae.The device was tested again on (b)(6) 2025, and tested positive for klebsiella pneumoniae ss.Pneumoniae in the biopsy channel.The device was tested again on (b)(6) 2025, and tested positive for escherichia coli.All channels were sampled.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.
Event or Problem Description
No additional information provided by the customer.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the review of the customer cleaning disinfection and sterilization (cds) processes, results of third-party testing, the device evaluation and the complaint investigation.Olympus reviewed the customer provided the cds processes where no obvious deviations from instructions for use (ifu) were identified.Olympus provided the following result of the culture test, performed at the third-party labs: sampling date: (b)(6) 2025 sampling from: air/water channel/suction channel cfu: <1cfu bacterial identification: n/a sampling date: nov 28, 2025 sampling from: instrument channel cfu: 2cfu bacterial identification: peribacillus sp the device was evaluated where no abnormalities were found that could have led to the reported event.Based on the results of the investigation, the reported event could not be confirmed, and a root cause could not be determined.Growth of microorganisms were reported 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.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE
• Common Device Name: SMALL INTESTINAL VIDEOSCOPE
• 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: 23719756
• Report Number: 9610595-2025-36787
• Device Sequence Number: 10208966
• Product Code: FDA
• UDI-Device Identifier: 04953170237423
• UDI-Public: 04953170237423
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K071254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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: SIF-Q180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2009
• 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