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

Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a monarch bronchoscopy procedure, the physician encountered navigation issues and elected to abort the case.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
Title: correction to section d ¿ suspect medical device (manufacturer address) detailed correction: manufacturer address, street line 1 ¿ previously: "santa clara" ¿ corrected to: "5490 great america pkwy".Manufacturer city ¿ previously: "95054" ¿ corrected to: "santa clara".Added manufacturer country code - usa.

• 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: 24378743
• Report Number: 3014447948-2026-00005
• Device Sequence Number: 10504898
• Product Code: EOQ
• UDI-Device Identifier: B634MON0000060
• UDI-Public: +B634MON0000060/16D20220516/120146
• 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,Followup
• Report Date (Section B): 03/26/2026

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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown