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

Model Number	BF-H1100
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the bronchovideoscope exhibited error code e315, failure to connect the equipment to the unit.The issue occurred before the unspecified procedure began (during preparation for use).The intended procedure could not be completed and was cancelled.It was reported that the patient was not sedated at the time.No patient adverse effects reported.There have been no reports of any patient injury or serious deterioration in their health from the cancelled procedure nor was there any indication that the procedure was being done emergently/urgently for life-threatening reasons.There was no evidence that the patient developed a permanent disability or permanent damage that caused substantial disruption in their ability to conduct normal life functions, and that additional medical or surgical intervention was required to preclude permanent impairment of a body function or damage to a body structure that is associated with the use of the olympus device.This event will be reassessed for potential change in reportability if further information is received.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.A device evaluation, a review of the device history record (dhr), as well as a historical trending analysis were conducted during this investigation.The subject device was returned, evaluated, and the user¿s report was confirmed.The device was displaying the e315 error code during the inspection.Additionally, the unit had experienced a perforation in the distal end that led to fluid invasion.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.Based on the results of the investigation and the condition of the returned device, a definitive root cause for the reported failure mode could not be determined.However, investigators believe it¿s likely that the reported failure was possible the result of a leaking at the distal end, which flooded the inside of the scope connector.That fluid exposure may have led to a short circuit or similar abnormality inside the scope, causing the reported error code.Olympus will continue to monitor the field performance of 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20473046
• Report Number: 9610595-2024-21262
• Device Sequence Number: 7629750
• Product Code: EOQ
• UDI-Device Identifier: 04953170424229
• UDI-Public: 04953170424229
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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-H1100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2020
• 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