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

Model Number	TJF-150
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned, evaluated, and as noted in b5 - the unit's tip was found dirty.Based on the results of the investigation, and the condition of the returned device, a definitive root cause for the reported failure mode could not be determined.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
It was discovered during the device evaluation, the olympus duodenovideoscope's tip was found dirty.There was no patient involvement during this event.

• Brand Name: 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 ; 5082077661
• MDR Report Key: 23926581
• Report Number: 9610595-2025-45033
• Device Sequence Number: 9296401
• Product Code: FDT
• UDI-Device Identifier: 04953170229459
• UDI-Public: 04953170229459
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/30/2025

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-150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2011
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown