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	Ischemic Heart Disease (2493)
Date of Event	08/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a robot-assisted bronchoscopy, anesthesia noted st-segment elevation after approximately six needle biopsy passes.The procedure was paused, and evaluation for pneumothorax was negative.An ekg assessment was initiated but temporarily interrupted by a building power outage.The patient was transferred to the cath lab, evaluated, and cleared.The patient had a history of cardiac issues and stent placement approximately eight months earlier.No device issues were reported.The procedure was aborted, and the patient was discharged home on (b)(6) 2026.

• Brand Name: Monarch Endoscopy Platform
• 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: 50480931
• Report Number: 3014447948-2026-00033
• Device Sequence Number: 10136312
• Product Code: EOQ
• UDI-Device Identifier: 10810068810988
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K243219
• 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): 08/27/2026

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: 08/11/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2023
• 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: Hospitalization
• Patient Sex: Unknown