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

Model Number	BF-TE2
Medical Device Problem Codes	Contamination (1120); Dent in Material (2526); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed that during the device evaluation, the bronchofiberscope light guide cover glass had corrosion.There was no patient involvement.
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: the customer was unable to adequately reprocess the device before sending the device to olympus.Based on the results of the investigation and historical data, reasonably known information suggests probable causes such as damage or deterioration of parts, environment problem like as dust/dirt/humidity, optical problem, overheating problem, and electrical problems like as signal loss or open circuit.The most probable cause of this complaint is expected or 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.
Additional Manufacturer Narrative
Updated fields: b5.Correction is being submitted to correct the e1 - title field.E1 - title changed to ni (no information).
Event or Problem Description
Update from the customer: the customer was not able to adequately reprocess the device before sending the device to olympus.
Event or Problem Description
Additional findings from the olympus service center: connecting tube has dirt deposition on it and the internal forceps channel port has a dent.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional findings from the olympus service center team.In addition, the following reportable malfunctions were identified during the device evaluation: connecting tube has dirt deposition on it and the internal forceps channel port has a dent a root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: cause linked to the device but unable to trace more specifically.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• 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 ; 5082077661
• MDR Report Key: 24753591
• Report Number: 9610595-2026-26272
• Device Sequence Number: 10145293
• Product Code: EOQ
• UDI-Device Identifier: 04953170339998
• UDI-Public: 04953170339998
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/01/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 03/26/2026; 04/17/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 04/01/2026; 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown