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

Model Number	GIF-H190
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	07/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report has been submitted by the importer under this mdr report number 2429304-2025-00003.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 via medwatch report that the subject videoscope was suspected to be involved in a salmonella infection to a patient.The report also indicated the patient was hospitalized.No further information was obtained.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Updated fields: h6.The device was not returned for evaluation; therefore, a definitive root cause could not be determined.The most probable cause was not established; the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Since this complaint was generated from a medwatch report, there is a lack of data, therefore evaluation is not possible.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 was received from the customer.

• Brand Name: EVIS EXERA III 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: 21057393
• Report Number: 9610595-2025-00011
• Device Sequence Number: 8153562
• Product Code: FDS
• UDI-Device Identifier: 04953170436758
• UDI-Public: 04953170436758
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131780
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: GIF-H190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White