MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. RHINO-LARYNGOFIBERSCOPE

Model Number	ENF-XP
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
No new information has been provided by the customer.
Additional Manufacturer Narrative
Updated: b5, h2, h4.
Additional Manufacturer Narrative
The device was returned to olympus for inspection.In addition, the investigation found that the insertion sleeve, the distal head, and the image guide cover lens are dirty.Based on the results of the investigation, the most probable cause of the additional reported failure(s) did not lead to a clear conclusion about the root cause of the reported event.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was observed that during the evaluation, the rhino-laryngofiberscope exhibited that the insertion sleeve, the distal head, and the image guide cover lens are dirty.There were no reports of patient involvement.

• Brand Name: RHINO-LARYNGOFIBERSCOPE
• Common Device Name: RHINO-LARYNGOFIBERSCOPE
• 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: 25037730
• Report Number: 9610595-2026-35118
• Device Sequence Number: 10411028
• Product Code: EOB
• UDI-Device Identifier: 04953170059018
• UDI-Public: 04953170059018
• Combination Product (Y/N): N
• PMA/510(K) Number: K221660
• 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,Followup
• Report Date (Section B): 05/09/2026

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: ENF-XP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2019
• 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