MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. VISERA TRACHEAL INTUBATION VIDEOSCOPE

Model Number	LF-V
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed during the device inspection that the visera tracheal intubation videoscope had corrosion under bending section cover at leak hole.There were no reports of patient involvement.
Additional Manufacturer Narrative
The subject device was returned for investigation.Based on the results of the investigation and the information provided, it is likely due to a degradation problem, that occur when the device becomes worn, weakened, corroded, or broken down due to processes such as aging, permeation, and corrosion.The most probable cause is a random component failure without any design or manufacturing issue.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: VISERA TRACHEAL INTUBATION VIDEOSCOPE
• Common Device Name: TRACHEAL INTUBATION 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: 23950339
• Report Number: 9610595-2026-00582
• Device Sequence Number: 7946690
• Product Code: EOQ
• UDI-Device Identifier: 04953170340246
• UDI-Public: 04953170340246
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2026

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: Health Professional
• Device Model Number: LF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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