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

Model Number	BF-Q180-AC
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the video of the evis exera ii bronchovideoscope was intermittent and dropped out when the scope was moved.The customer did not know the date or when the issue occurred.There was no reported patient harm or impact due to this event.
Additional Manufacturer Narrative
During device evaluation at olympus, it was found the complaint was confirmed and the image was intermittent and flickering.After aeration, the image was improved with no stains and flickering found.The electrical connector was dry after aeration and dry corrosion was found.The scope did pass the dunk test.This event is under investigation.A supplemental report will be submitted upon receiving additional information.
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, it is likely that the contact/conduction failure of internal circuit board occurred due to water that invaded the subject device, causing the suggested event.The event can be prevented by following the instructions for use which state: 1.4 precautions: when reprocessing evis videoscopes, confirm that the water-resistant cap is securely attached to the endoscope connector before immersion in reprocessing fluids.3.4 leakage testing: performing the leakage test: - never connect or disconnect the water-resistant cap or the leakage tester¿s connector cap while immersed.Doing so could allow water to enter the endoscope and equipment damage can result.- when connecting the leakage tester¿s connector cap to the water-resistant cap¿s venting connector, make sure that the inside of the leakage tester¿s connector cap and the outside of the water-resistant cap¿s venting connector are thoroughly wiped and dry.Water remaining on either component may penetrate the inside of the water-resistant cap and could cause endoscope malfunction." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II 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: 16181822
• Report Number: 9610595-2023-00819
• Device Sequence Number: 11405673
• Product Code: EOQ
• UDI-Device Identifier: 04953170340086
• UDI-Public: 04953170340086
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K050220
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2023

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-Q180-AC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• 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: 12/20/2022
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 05/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2011
• 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