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

Model Number	MBR-000211-B
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	01/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report is based on information which has been investigated or verified.Based on the information available for this complaint, the root cause of the reported pneumothorax is related to a known inherent risk of the device and procedure as documented in the labeling.A visual examination of the scope handle, shaft, and tip observed no external damage except observed kink in the scope jacket 10mm from the scope handle.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 bronchoscope did not meet specifications due to observed kink on scope jacket.
Event or Problem Description
It was reported that during a monarch bronchoscopy procedure the patient experienced a pneumothorax in the right lung.A chest tube was placed and patient was hospitalized.The following day the chest tube was removed and the patient was released.The physician stated that the scope appeared to be kinked and the physician elected to abort the case.

• Brand Name: MONARCH BRONCHOSCOPE
• 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 94065
• Manufacturer Contact: harminder kaur ; 150 shoreline dr.; redwood city, CA 94065 ; 6282544750
• MDR Report Key: 18597523
• Report Number: 3014447948-2023-00035
• Device Sequence Number: 15499465
• Product Code: QNW
• UDI-Device Identifier: B634MBR000211B1
• UDI-Public: +B634MBR000211B1/14D20240420E
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• 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): 01/29/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2024
• Device Model Number: MBR-000211-B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown