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

Model Number	MBR-000211-B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	08/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during monarch bronchoscopy procedure patient experienced pneumothorax.Lesion in the lingula 1.7 x 9 cm.Lesion was peripheral.Chest tube was placed, the patient was hospitalized, and released on (b)(6) 2022.The case was completed and the physician did not attribute the event to the monarch specifically.Other instruments used in this case were the arcpoint needle, olympus cytology brush, olympus micro brush, and olympus endojaw disposable biopsy forceps.
Additional Manufacturer Narrative
The root cause of the reported event is related to a known inherent risk of the device and procedure as documented in the labeling.No corrective action is required at this time.During the investigation of this returned device, a visual inspection found no external damage of the device or its return packaging.The ability of the device to latch was tested on multiple test fixtures as well as an in-house monarch system on both instrument device manipulators (idm).Structural dimensional verification confirmed all measurements to be within specification.Bench testing was performed on the returned device to verify electrical functionality of the camera, light emitting diode (led), and electromagnetic sensors (em).The result of the tests found the device to be within specifications.The device was then loaded to an in-house system and driven through a lung model.The device functioned as expected.Based on the results from the examination, the monarch bronchoscope used on the monarch platform has met specifications and there were no issues found with the monarch bronchoscope.Risk document number: 105-000198-01, rev.E, monarch bronch risk management report.

• 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 ; 5106057113
• MDR Report Key: 15370487
• Report Number: 3014447948-2022-00028
• Device Sequence Number: 6090086
• Product Code: QNW
• UDI-Device Identifier: B634MBR000211B0
• UDI-Public: +B634MBR000211B0/14D20221107E
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/07/2022

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
• Device Expiration Date: 11/07/2022
• Device Model Number: MBR-000211-B
• Device Catalogue Number: MBR-000211-B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown