MAUDE Adverse Event Report: AURIS HEALTH, INC. MONARCH 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 Codes	Pneumothorax (2012); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject scope was connected to a bench test fixture to verify electrical functionality of the camera, light emitting diode (led), and electromagnetic sensors (em).The scope tip was manually articulated while monitoring the resistance of each sensor to confirm that there was no intermittent open on either sensor or camera image degradation.The results showed observed both sensors to be within specification.A closer inspection of the scope handle, shaft, cable, and connector observed no external physical damage that could contribute to the reported issue.The results showed the bronchoscope to be operating as expected.A review of the calibration data obtained from production final acceptance testing revealed all acceptance criteria were met and no anomalies found.Based on the results from the examination, the product met specifications.A review of similar investigations with similar reported issue (1200 fault or em sensing issue) has noted that this is a known issue and have not established a possible root cause.The incident will continue to be monitored in regular trend review meetings.
Event or Problem Description
It was reported that after a successful diagnostic procedure using the monarch bronchoscopy system, a pneumothorax and pneumomediastinum were noted post-procedure.A chest tube was placed and the patient was admitted to the hospital.The pneumothorax and pneumomediastinum resolved and the patient was discharged.

• 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 94065
• Manufacturer Contact: andria smith ; 150 shoreline drive; redwood city, CA 94065 ; 5745510671
• MDR Report Key: 17509786
• Report Number: 3014447948-2023-00015
• Device Sequence Number: 12338169
• Product Code: EOQ
• UDI-Device Identifier: B634MBR000211A1
• UDI-Public: +B634MBR000211A1/14D202310230
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K203614
• 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
• Report Date (Section B): 08/11/2023

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: MBR-000211-A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown