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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a robotically assisted bronchoscopy procedure targeting a right upper lobe nodule, as the physician advanced the radial probe it was noticed that the patient turned purple.The team immediately aborted the procedure and removed the bronchoscope and radial probe.The patient coded but was revived and transferred to the medical intensive care unit (micu).Patient is stable and discharged from hospital on (b)(6) 2026.No biopsies were taken, and there were no reported issues with the devices.The physician attributed the event to anesthesia and the patient¿s underlying health issue.

• Brand Name: MONARCH ENDOSCOPY PLATFORM
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES
• Manufacturer (Section D): AURIS HEALTH, INC.; 5490 great america pkwy; santa clara CA 95054
• Manufacturer Contact: april king ; 5490 great america pkwy; santa clara, CA 95054 ; 4082161590
• MDR Report Key: 25105317
• Report Number: 3014447948-2026-00019
• Device Sequence Number: 18830610
• Product Code: EOQ
• UDI-Device Identifier: B634MON0000060
• UDI-Public: +B634MON0000060/16D20210122
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K211493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH BRONCHOSCOPE; RADIAL PROBE (UNKNOWN)
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization
• Patient Sex: Unknown