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

Model Number	BF-1TH1100
Medical Device Problem Codes	Break (1069); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported the distal end of the subject device burnt after using argon probe."argon probe is said to have had a lateral crack".Per the report, the issue was found "after procedure (upon completion of procedure, device no longer used on patient).There was no patient harm, no injury reported due to the event.
Event or Problem Description
It was reported the distal end of the subject device burnt after using argon probe."argon probe is said to have had a lateral crack".Per the report , the issue was found "after procedure (upon completion of procedure, device no longer used on patient).There was no patient harm, no injury reported due to the event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Updated fields: d8, d9, h3, h4, h6, h11.The device was returned to olympus for inspection and the reported failure was confirmed.In addition, the following reportable malfunctions were identified during the device evaluation: c-cover burnt.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: cause not established.Olympus will continue to monitor field performance for this device.

• Brand Name: BRONCHOVIDEOSCOPE
• Common Device Name: BRONCHOVIDEOSCOPE
• 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: 20870104
• Report Number: 9610595-2024-40408
• Device Sequence Number: 8565003
• Product Code: EOQ
• UDI-Device Identifier: 04953170424199
• UDI-Public: 04953170424199
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K222861
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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: Health Professional
• Device Model Number: BF-1TH1100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARGON PROBE
• Patient Sex: Unknown