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	07/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a bronchoscopy procedure the patient experienced a pneumothorax during the removal bronchoscope.The patient was hospitalized, and a chest tube was placed.The chest tube was removed, and the patient was discharged two days later.The target location was left upper lobe (lul).It was reported that a huge snapping and straightening of the bronchoscope occurred during the removal.
Additional Manufacturer Narrative
Risk of pneumothorax is documented in (b)(4), rev f, monarch bronchoscope risk management report and is deemed to be acceptable.Based on the information available for this complaint, the root cause of the reported event is related to a known inherent risk of the device and procedure as documented in the labeling.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: 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.The customer reported that the scope appeared to have ¿auto relax without being initiated, no errors occurred on the screen.¿ it was also reported that the case was completed but the patient had suffered a pneumothorax after the scope was removed.A review of the case video showed that fault id: 1001-50-0-0 ¿controller hw error¿ had occurred when the customer was retracting from the patient.A fault id: 1001-50-0-0 ¿controller hw error¿ is defined as ¿when system is in drive mode and pendant is upside down or experiences an impact or experiences free-fall.¿ it is likely that if the customer briefly lost control of the controller, the scope would have lost tension and appeared to have ¿auto relaxed¿.A review of the calibration data obtained from product final acceptance testing revealed all acceptance criteria were met and no anomalies found.Based on the results from the examination, the product met specifications.

• 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: 15249489
• Report Number: 3014447948-2022-00023
• Device Sequence Number: 17594574
• Product Code: QNW
• UDI-Device Identifier: B634MBR000211A1
• UDI-Public: +B634MBR000211A1/14D20221010
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/09/2022

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: 10/10/2022
• Device Model Number: MBR-000211-A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2022
• 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