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	04/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the bronchovideoscope had no endoscopic image.The issue occurred during a diagnostic procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
It was initially reported that there was no image at the start of the procedure.Subsequently, it was confirmed there was a forty minute delay while the patient was under general anesthesia.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report has been submitted by the importer under this mdr report number 2429304-2024-00255.
Event or Problem Description
It was reported that the subject device did not have an image at the beginning of navigational bronchoscopy after inserting the scope down the patient's endotracheal tube.The camera started to have issues and the doctor could not see the patient's anatomy resulting in a forty minute delay while under general anesthesia.There was an error message, n207 present.The navigational bronchoscopy was not completed and the patient was not harmed due to the reported event.They then proceeded with the second procedure, a endobronchial ultrasound.
Additional Manufacturer Narrative
Results of lm investigation.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 possible that image disappeared during procedure due to insufficient inspection of the device prior to use, causing delay of procedure.However, a specific cause was not established.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu): operation manual preparation and inspection, inspection of the endoscopic system, inspection of the endoscopic image "turn the up/down and right/left angulation control knobs slowly in each direction until they stop.Confirm that the wli and nbi endoscopic images do not momentarily disappear or display any other irregularities." 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: 19164504
• Report Number: 9610595-2024-08467
• Device Sequence Number: 7085535
• Product Code: EOQ
• UDI-Device Identifier: 04953170340147
• UDI-Public: 04953170340147
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BF-XT160
• Was Device Available for Evaluation?: No
• 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: 04/18/2024
• Supplement Date Received by Manufacturer: 05/06/2024; 06/10/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 05/15/2024; 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: G-GASTRO MONITOR.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Female