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

Model Number	BF-TE2
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: BRONCHOFIBERSCOPE
• Common Device Name: BRONCHOFIBERSCOPE
• 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 ; +1(508)207-7661
• MDR Report Key: 50828727
• Report Number: 9610595-2026-77073
• Device Sequence Number: 10581166
• Product Code: EOQ
• UDI-Device Identifier: 04953170339998
• UDI-Public: 04953170339998
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K023984
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: BF-TE2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/21/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/22/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2012
• 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