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

Model Number	MON-000006
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a diagnostic procedure using the monarch bronchoscopy system, bleeding was noted.The physician converted the procedure to a traditional bronchoscopy and a balloon was used to provide tamponade.Per the physician, the primary cause of the patient bleed was due to the patient¿s fragile airways and pre-existing condition.There was no reported device malfunction associated with the adverse event.No hospitalization required.
Additional Manufacturer Narrative
Engineering confirmed the reported event of bleeding through investigation of the procedure video.A review of the procedure video by clinical engineering did not find evidence that the monarch bronchoscope caused any damage to the airways, causing the bleeding.The root cause of the bleeding is not clear from the video.Investigation of system logs by failure analysis engineering concluded that the monarch system behaved as intended.A device history record (dhr) review for the system was performed and no non-conformances were found that relate to the reported issue.This issue will continue to be monitored in regular trend review meetings.Based on the information available, there is no evidence to support that the monarch system caused the bleeding described.

• Brand Name: MONARCH PLATFORM
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES
• Manufacturer (Section D): AURIS HEALTH, INC.; 150 shoreline drive; redwood city CA 94065
• Manufacturer (Section G): AURIS HEALTH, INC.; 150 shoreline drive; redwood city CA
• Manufacturer Contact: monica nachbar ; 150 shoreline drive; redwood city 94065 ; 6502085208
• MDR Report Key: 17618092
• Report Number: 3014447948-2023-00018
• Device Sequence Number: 6246906
• Product Code: EOQ
• UDI-Device Identifier: B634MON000005010
• UDI-Public: +B634MON000005010/16D20210831
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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: MON-000006
• 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: 07/27/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2021
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown