MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA GASTROINTESTINAL VIDEOSCOPE

Model Number	GIF-2T160
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 gastrointestinal videoscope tested positive for bacillus cereus.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.
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 complaint investigation.Updated fields: d8, d9, h4, h6, h11.Olympus provided the following result of the culture test, performed at the third-party labs.Sampling date: (b)(6) 2026, sampling from: air/water channel, cfu: 1, bacterial identification: bacillus species.Sampling date: (b)(6) 2026, sampling from: auxiliary channel, cfu: <1, bacterial identification: none.Sampling date: (b)(6) 2026, sampling from: instrument channel, cfu: >80, bacterial identification: bacillus cereus.Sampling date: (b)(6) 2026, sampling from: instrument channel, cfu: 16, bacterial identification: bacillus cereus.Sampling date: (b)(6) 2026, sampling from: suction channel, cfu: >80, bacterial identification: bacillus cereus.Sampling date: (b)(6) 2026, sampling from: air/water channel, auxiliary channel, cfu: <1, bacterial identification: none.Sampling date: (b)(6) 2026, sampling from: instrument channel, cfu: >80, bacterial identification: others.Sampling date: (b)(6) 2026, sampling from: instrument channel, cfu: 13, bacterial identification: bacillus cereus, peribacillus sp.Sampling date: (b)(6) 2026, sampling from: suction channel, cfu: >80, bacterial identification: bacillus cereus.Sampling date: (b)(6) 2026.Sampling from: air/water channel, auxiliary channel, instrument channel, suction channel, cfu: <1, bacterial identification: none.Sampling date: (b)(6) 2026, sampling from: instrument channel, cfu: 2, bacterial identification: staphylococcus warneri.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Despite good faith efforts being made, additional information was not able to be obtained.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 before repair, the results conformed to the regulation's recommendation.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 from the customer.
Event or Problem Description
No additional information from the customer concerning the reported problem.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide a correction.Corrected fields: e1 - initial reporter establishment name, e1 - address 1, (b)(6).

• Brand Name: EVIS EXERA GASTROINTESTINAL VIDEOSCOPE
• Common Device Name: GASTROINTESTINAL 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: 23752574
• Report Number: 9610595-2025-37631
• Device Sequence Number: 9321418
• Product Code: FDS
• UDI-Device Identifier: 04953170066610
• UDI-Public: 04953170066610
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2026

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: Health Professional
• Device Model Number: GIF-2T160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 04/08/2026; 04/23/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 04/17/2026; 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2011
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown