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

Model Number	LF-DP
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: peeling of the image guide tube coating greater than 2 mm or more.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 flexible scope exhibited peeling of the coating of the ig tube (1mm2 or more).There was no patient involvement.

• Brand Name: TRACHEAL INTUBATION FIBERSCOPE
• Common Device Name: TRACHEAL INTUBATION FIBERSCOPE
• 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: 21611610
• Report Number: 9610595-2025-03926
• Device Sequence Number: 15341956
• Product Code: EOQ
• UDI-Device Identifier: 04953170340192
• UDI-Public: 04953170340192
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K981543
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2025

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: LF-DP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 03/14/2025
• 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