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

Model Number	BF-XP290
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus, testing and inspection found that the device had no image.This complaint is most likely the result of a broken image sensor.Testing and inspection also found the following: the customer¿s complaint was confirmed, due to wear of the angle wire, the bending angle in the up direction became longer than normal.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
The customer reported to olympus that the device cannot angulate sufficiently.There were no reports of patient harm associated with this event.The subject device was sent back to olympus for evaluation.During inspection and testing the following was found: no image.This report is being submitted for the malfunction found during evaluation (no image).
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 root cause of the event was unable to be identified.It is likely the image sensor unit has been damaged (disconnection, etc.), or the mounted parts (ic chip, capacitor, etc.) of the electric board have failed due to use stress, external factors, or handling.The inspection method for the event is described as follows in the instructions for use (ifu) "chapter 3 preparation and inspection 3.8 inspection of combination function with related equipment".[inspection of endoscopic images] check that normal light observation and nbi observation images (excluding bf-mp290f) are projected properly.1 observe the palm, etc.Using normal light observation images and nbi observation images (excluding bf-mp290f).2 confirm that the illumination light is emitted.3 adjust the light intensity to an appropriate brightness.4 check that there are no abnormalities such as noise, blurring, or cloudiness in the normal light observation image and nbi observation image (excluding bf-mp290f).5 operate the ud angle lever of the endoscope to bend the curved part.6 operate the insertion tube rotation ring of the endoscope to rotate the insertion tube.7 check that normal light observation images and nbi observation images (except for bf-mp290f) do not disappear for a moment.8 align the up index on the insertion tube rotating ring with the up index on the operation unit." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE 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: 16816874
• Report Number: 9610595-2023-06741
• Device Sequence Number: 7124497
• Product Code: EOQ
• UDI-Device Identifier: 04953170063039
• UDI-Public: 04953170063039
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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-XP290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2014
• 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