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

Model Number	BF-XT160
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that his olympus evis exera bronchovideoscope wasn¿t displaying an image during procedure preparation.According to the initial reporter, there were no error messages present and the room was given a new scope to continue the procedure.There was no patient harm reported as a result of this event.
Additional Manufacturer Narrative
The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user¿s report was partially confirmed.The object lens was dirty and causing the image to appear blurry.Additionally, there was a deep cut in the insertion tube, causing it to fail the ring gauge test.If additional information becomes available following the device evaluation, a supplemental report will be filed.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the foreign material could not be identified nor the root cause of it.The event can be detected/prevented by handling the device in accordance with the following instructions for use: type xt160 operation manual chapter 3 preparation and inspection shows how to detect the event.Type xt160 reprocessing manual chapter 3 cleaning, disinfection and sterilization procedures shows how to prevent the event.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: 17442298
• Report Number: 9610595-2023-11006
• Device Sequence Number: 19510953
• Product Code: EOQ
• UDI-Device Identifier: 04953170340147
• UDI-Public: 04953170340147
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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-XT160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2023
• 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: 07/24/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2010
• 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