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

Model Number	MON-000005-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	12/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.There was no allegation of device failure.The risk of pneumothorax is documented in 105-000299-01 monarch bronch risk management report.Based on the information available for this event, the root cause is related to a known inherent risk of the device and procedure as documented in the device labeling.
Event or Problem Description
The following medical literature was reviewed: robotic bronchoscopy: factors associated with diagnostic accuracy of robotic bronchoscopy with 12-month follow-up: authors: abhinav agrawal, md, elliot ho, do, udit chaddha, mbbs, baris demirkol, md, sivasubramanium v.Bhavani, md, d.Kyle hogarth, md, fccp, septimiu murgu, md, fccp.Citation:doi:https://doi.Org/10.1016/j.Athoracsur.2021.12.041.It was reported pneumothorax and patient hospitalize.No device issues were reported.

• 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 94065
• Manufacturer Contact: harminder kaur ; 150 shoreline drive; redwood city, CA 94065 ; 6282544750
• MDR Report Key: 19251075
• Report Number: 3014447948-2024-00009
• Device Sequence Number: 17737564
• Product Code: EOQ
• UDI-Device Identifier: B634MON000005010
• UDI-Public: +B634MON000005010/16D20201007
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2024

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-000005-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2020
• 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