MAUDE Adverse Event Report: AURIS HEALTH, INC. MONARCH BRONCHOSCOPE; 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 Code	Pneumothorax (2012)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the first, and only case of the day (1:45pm), the right lower lobe (rll) lesion 1.5cm expected infection, physician did 4 brushes and patient sustained a small pneumothorax.A chest tube was placed taking a week to resolve.Auris forceps, a micro brush (brand was not recorded), and an olympus periview flex tbna needle were all used in this case.Patient was admitted and a chest tube was placed.The chest tube was removed on (b)(6) 2022 and the patient was discharged the same day.The patient is currently doing well.The physician does not attribute the pneumothorax to the monarch system.
Additional Manufacturer Narrative
The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a visual examination of the scope handle, shaft, and tip observed no external damage.To verify the scope latched onto the instrument device manipulator (idm), the scope was then connected and disconnected to 2 different idm top plates 10x each.The scope was then connected and disconnected to 2 different benchtop idm fixtures 10x each.The scope was then connected and disconnected onto an in-house system on both idms 10x each.No latching issue was observed.Dimensional verification for any structural anomalies yielded no variance observed.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 results showed the bronchoscope to be operating as expected.The scope was then connected to an in-house system and to confirm the functionality of the scope.The results showed the bronchoscope to be operating 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: 105-000299-01, rev f, monarch bronchoscope 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: 15370728
• Report Number: 3014447948-2022-00029
• Device Sequence Number: 1726424
• Product Code: QNW
• UDI-Device Identifier: B634MBR000211A1
• UDI-Public: +B634MBR000211A1/14D20220925E
• 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,Followup
• Report Date (Section B): 09/14/2022

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: 09/25/2022
• Device Model Number: MBR-000211-A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2022
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown