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

Model Number	TJF-Q190V
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the duodenovideoscope to the service center for a separate issue.During the device analysis a foreign material was found inside the forceps passage.There was no patient involvement.
Additional Manufacturer Narrative
The device was returned to olympus for inspection.Based on the results of the investigation, a definitive root cause could not be identified.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III DUODENOVIDEOSCOPE
• Common Device Name: DUODENOVIDEOSCOPE
• 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 ; +1(508)207-7661
• MDR Report Key: 50947916
• Report Number: 9610595-2026-80565
• Device Sequence Number: 10446676
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K251867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: Other
• Device Model Number: TJF-Q190V
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/01/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2022
• 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