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

Model Number	LF-V
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a therapeutic toupet funduplication, the sheath of the tracheal intubation videoscope tore and fell into the patient¿s trachea.The piece was retrieved with suction.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
This supplemental emdr is being submitted to correct coding.If additional information becomes available, or upon the completed investigation, an emdr supplement will be submitted.
Event or Problem Description
No additional information was received from the customer.
Additional Manufacturer Narrative
Update to h6.Correction to b1.The device was returned to olympus for inspection, and the following reportable malfunction was identified: detachment of the bending section.The reported issue of detachment was confirmed.The device was received with a piece missing from the insertion tube/bending section, but the specific missing piece found in the patient¿s trachea was not returned for further identification.However, a photograph confirmed the bending cover glue/a-rubber glue was missing from the insertion tube side.A review of the device history record found no deviations that could have caused or contributed to the reported issue.A definitive root cause could not be identified.Based on the results of the investigation, the most probable cause of the detachment is 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.
Event or Problem Description
No additional information was received from the customer.

• 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: 23471850
• Report Number: 9610595-2025-29411
• Device Sequence Number: 21244837
• Product Code: EOQ
• UDI-Device Identifier: 04953170340246
• UDI-Public: 04953170340246
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 02/02/2026; 04/20/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 02/02/2026; 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown