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

Model Number	TJF-150
Medical Device Problem Codes	Crack (1135); Material Discolored (1170); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection.The legal manufacturer reviewed the customer provided cleaning disinfection and sterilization (cds) processes where no obvious deviations from instructions for use (ifu) were identified.A root cause could not be identified.Based on the results of the investigation, most probable cause for the events discoloration inside light guide lens, the adhesive around the light guide lens had chipped was traced to component failure.A root cause could not be identified.Based on the results of the investigation, it is likely the most probable cause of the forceps elevator wire had contained foreign objects could not be established.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 observed that during the device evaluation, the duodenoscope exhibited discoloration inside light guide lens, adhesive around the light guide lens had chipped and forceps elevator wire had contained foreign objects.There was no patient involvement.

• 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: 23560168
• Report Number: 9610595-2025-32217
• Device Sequence Number: 9829639
• Product Code: FDT
• UDI-Device Identifier: 04953170229459
• UDI-Public: 04953170229459
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2025

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: 09/13/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2010
• 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