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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	07/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a post-procedure cxr (chest x-ray) revealed a pneumothorax, in the left upper lobe, in a patient had come in for a bronchoscopy procedure.The patient was hospitalized, and a chest tube was placed.The chest tube was removed, and the patient was discharged on (b)(6) 2022.There were no faults or device malfunctions reported during the procedure.
Additional Manufacturer Narrative
This event was reported from the needle-based confocal laser endomicroscopy to aid in lung nodule localization by robotic-assisted navigational bronchoscopy (clear) study.The device was not returned for evaluation.There was no allegation of device failure.The risk of pneumothorax is documented in (b)(4), rev f, 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.

• Brand Name: MONARCH PLATFORM
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES
• Manufacturer (Section D): AURIS HEALTH, INC.; 150 shoreline dr.; redwood city CA 94065
• Manufacturer (Section G): AURIS HEALTH, INC.; 150 shoreline dr.; redwood city CA 94065
• Manufacturer Contact: andria smith ; 150 shoreline dr.; redwood city, CA 94065 ; 5745510671
• MDR Report Key: 15211833
• Report Number: 3014447948-2022-00021
• Device Sequence Number: 11962089
• Product Code: EOQ
• UDI-Device Identifier: B634MON000005010
• UDI-Public: +B634MON000005010/16D20210930
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K193534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2022

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: 07/19/2022
• Initial Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male