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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pneumothorax (2012)
Date of Event	09/13/2023
Type of Reportable Event	Death
Event or Problem Description
During bronchoscopy, the patient became hypotensive.The critical care pulmonology team was called to the bedside.A chest tube was inserted and an immediate gush of air was observed.Shortly thereafter the patient arrested and cpr was initiated.A larger-bore chest tube was placed, resulting again in a gush of air.The patient was pronounced dead by the critical care team.Necrotic material was expelled during the event.A rab (robot-assisted bronchoscopy) with 7-needle aspiration was performed.The death was presumed to be due to a tension pneumothorax.No issues were reported with the devices used during the procedure.

• Brand Name: MONARCH ENDOSCOPY PLATFORM (MONARCH 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; 95054, CA ; 4082161590
• MDR Report Key: 24274522
• Report Number: 3014447948-2026-00004
• Device Sequence Number: 13442554
• Product Code: EOQ
• UDI-Device Identifier: B634MON0000060
• UDI-Public: +B634MON0000060/16D20220301
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

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: 01/08/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2022
• 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: PERIVIEW NEEDLE
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Sex: Unknown