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

Model Number	MBR-000211-A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a monarch procedure the physician was unable to turn the bronchoscope on after removing the scope from the patient's trachea due to the camera image being grainy and ultimately going black.The physician elected to abort the case.There were no reported clinical consequences to the patient.

• 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: 21621388
• Report Number: 3014447948-2025-00006
• Device Sequence Number: 8516249
• Product Code: QNW
• UDI-Device Identifier: B634MBR000211A1
• UDI-Public: +B634MBR000211A1/14D202505232
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K231473
• 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): 04/15/2025

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
• Device Model Number: MBR-000211-A
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2024
• 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