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	Foreign Body In Patient (2687)
Date of Event	07/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.A thorough visual inspection, both externally and internally with a baroscope, found no missing parts or pieces that would account for a white fb that could have been from the scope.It was requested that the customer send back the ¿white fb¿ piece for failure analysis investigation.However, the customer had discarded the white fb.The fluidics tubing and auris forceps were also discarded before being returned for investigation.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.A review of investigations has noted that this is an isolated issue and has no established a root cause.
Event or Problem Description
It was reported that the physician navigated to the lesion, and when the radial endobronchial ultrasound (rebus) probe was introduced, it pushed a small white foreign body (fb) out of the monarch scope into the patient's lungs.The physician was able to remove the fb using forceps and the procedure was completed successfully.
Additional Manufacturer Narrative
H10: the reported issue occurred on a device used for diagnosis and not treatment.Because the reported issue is associated with scope performance, an examination of the subject scope was performed.The customer reported that when the customer introduced radial endobronchial ultrasound (rebus) probe it pushed a piece of white plastic out of the monarch scope into the patient's lungs.Customer was able to remove a piece of plastic with forceps and was able to complete the case.A review of complaint history reported issue (fragment fell in patient) has noted that this is an isolated issue and the first event of its kind but has not established a root cause.

• 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 drive; redwood city CA 94065
• Manufacturer Contact: harminder kaur ; 150 shoreline drive; redwood city, CA 94065 ; 5106057113
• MDR Report Key: 15230044
• Report Number: 3014447948-2022-00022
• Device Sequence Number: 11905188
• Product Code: QNW
• UDI-Device Identifier: B634MBR000211A1
• UDI-Public: +B634MBR000211A1/14D20221010/
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2022

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: 07/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 08/31/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown