MAUDE Adverse Event Report: AURIS HEALTH, INC. MONARCH BRONCHOSCOPE; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	MBR-000211-A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Monarch bronchoscope gave error message "navigation em" once connected to the docking station and patient.Scope removed from patient and packaged up.

• Brand Name: MONARCH BRONCHOSCOPE
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): AURIS HEALTH, INC.; 5490 great america parkway; santa clara CA 95054
• MDR Report Key: 25229150
• Report Number: 25229150
• Device Sequence Number: 15420237
• Product Code: EOQ
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/11/2026
• Report Date (Section F): 05/11/2026

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: MBR-000211-A
• Device Catalogue Number: MBR-000211-A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Female
• Date Report Sent to FDA: 05/11/2026