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

Model Number	TJF-150
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the duodenovideoscope to the service center for an unrelated issue.During the device evaluation, technicians identified that the universal cord was sticky and the knob wire contained foreign objects.Based on the completed investigation, the identity of the foreign object and the root cause of why it remained in the device could not be definitively determined.It is likely that the reprocessing deviated from the instruction for use.Additionally, the cause of the stickiness on the universal cord was not established.There was no patient involvement.
Additional Manufacturer Narrative
B2) date of event is unknown.Additional information will be provided if available.Based on the completed investigation, the identity of the foreign object and the root cause of its retention within the device could not be definitively determined.It is likely that reprocessing deviated from the instructions for use.Additionally, the cause of the stickiness observed on the universal cord could not be established.The event (universal cord is sticky) is detectable and preventable by handling device in accordance with the following ifu: ifu figure number:rc3954 revision:02 chapter: tjf type 150 operation manual chapter 3 preparation and inspection,3.3 preparation and inspection of accessories should any additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor the field performance of this device.

• 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: 25354956
• Report Number: 9610595-2026-44520
• Device Sequence Number: 13234541
• Product Code: FDT
• UDI-Device Identifier: 04953170307553
• UDI-Public: 04953170307553
• 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): 06/01/2026

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-150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2018
• 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