MAUDE Adverse Event Report: Auris Health, Inc. Monarch; Bronchoscope (flexible or rigid) and accessories

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a robot-assisted bronchoscopy procedure, bleeding occurred and was controlled within minutes using cold saline and a balloon blocker.The patient remained stable, the procedure was aborted, and the patient was discharged home later that day ((b)(6)2026).

• Brand Name: Monarch
• Common Device Name: Bronchoscope (flexible or rigid) and accessories
• Manufacturer (Section D): Auris Health, Inc.; 5490 great america parkway; santa clara CA 95054
• Manufacturer Contact: april king ; 5490 great america pkwy; santa clara, CA 95054 ; +1(408)216-1590
• MDR Report Key: 50008426
• Report Number: 3014447948-2026-00032
• Device Sequence Number: 12931845
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/23/2026

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: 07/14/2026
• Initial Report FDA Received Date: 07/27/2026
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown