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

Model Number	BF-3C160
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was no image when using the bronchovideoscope.There was no patient harm associated with the event.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the legal manufacturer¿s final investigation additional data: e2,e3,g2.A review of device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue were identified.The device was returned to olympus for inspection, and the customer's reportable malfunction was confirmed.Based on the results of the investigation, a definitive cause was not identified.However, it is likely the event occurred by breakage of image sensor unit.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: olympus will continue to monitor field performance for this device.This supplemental report is being submitted to provide the legal manufacturer¿s final investigation additional data: e2,e3,g2.A review of device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue were identified.The device was returned to olympus for inspection, and the customer's reportable malfunction was confirmed.Based on the results of the investigation, a definitive cause was not identified.However, it is likely the event occurred by breakage of image sensor unit.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA 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: 19564110
• Report Number: 9610595-2024-12294
• Device Sequence Number: 6974796
• Product Code: EOQ
• UDI-Device Identifier: 04953170340031
• UDI-Public: 04953170340031
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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-3C160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2007
• 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