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

Model Number	GIF-H180J
Medical Device Problem Codes	Poor Quality Image (1408); Microbial Contamination of Device (2303); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
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 23 colony forming units (cfus) of 200 microlitres bacteria or fungi, 11 cfu of 200 microlitres stenotrophomonas maltophilia, and 12 cfu of 200 microlitres ochrobactrum intermedium.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
Updated information added to d9, e4, h2, h3, h6, h8 and h11.This report is being supplemented to provide additional information based on the results of third-party testing, the device evaluation, and the complaint investigation.Despite good faith efforts being made, the cleaning disinfection and sterilization (cds) information could not be obtained.Olympus provided the following results of the culture test, performed at the third-party labs: sampling date: (b)(6) 2026 sampling from: air/water channel cfu: 1 cfu/endoscope bacterial identification: paenibacillus sp sampling date: (b)(6) 2026 sampling from: auxiliary channel cfu: <1 cfu/endoscope bacterial identification: n/a sampling date: (b)(6) 2026 sampling from: instrument channel cfu: 5 cfu/endoscope bacterial identification: psychrobacillus sp, paenibacillus sp sampling date: (b)(6) 2026 sampling from: suction channel cfu: 21 cfu/endoscope bacterial identification: bacillus species sampling date: (b)(6) 2026 sampling from: air/water channel cfu: <1 cfu/endoscope bacterial identification: n/a sampling date: (b)(6) 2026 sampling from: auxiliary channel cfu: <1 cfu/endoscope bacterial identification: n/a sampling date: (b)(6) 2026 sampling from: instrument channel cfu: 5 cfu/endoscope bacterial identification: peribacillus simplex sampling date: (b)(6) 2026 sampling from: suction channel cfu: 14 cfu/endoscope bacterial identification: kocuria sp, paenibacillus sp, peribacillus simplex, rossellomorea sp the device was evaluated, and the following reportable malfunctions were identified during the device evaluation: due to corrosion on the electrical connector, a noisy image occurred, and due to dirt on the light guide rod, illumination was poor.Based on the results of the investigation, olympus confirmed foreign material was present within the device, but the type of material cannot be identified.However, the following likely led to the malfunction: the foreign material was possibly not removed completely if the reprocessing steps were not conducted properly.A review of the device history record found no deviations that could have caused or contributed to the reported issue.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 was reported through culture testing by the user after reprocessing.However, when olympus culture was tested after reprocessing in accordance with the instructions for use (ifu) 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 received from customer.

• Brand Name: EVIS EXERA II 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: 24604676
• Report Number: 9610595-2026-21366
• Device Sequence Number: 8895205
• Product Code: FDS
• UDI-Device Identifier: 04953170307539
• UDI-Public: 04953170307539
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K051645
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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-H180J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2015
• 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