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

Model Number	MON-000006
Medical Device Problem Codes	Application Program Problem (2880); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a diagnostic procedure using the monarch bronchoscopy system, the physician decided to abort the diagnostic procedure due to navigational difficulty.The patient was reported to have a lot of mucus.The physician decided to abort the diagnostic procedure.There was no reported device malfunction associated with the adverse event.No medical or surgical intervention reported.No hospitalization required.
Additional Manufacturer Narrative
Engineering determined that the navigational difficulty was due to a software algorithm limitation that failed to segment the patient anatomy correctly.The algorithm limitation lead to the poor virtual view rending near the target.A review of the device history record (dhr) was performed.There are no reports of nonconformance that relate to the reported incident.A review for similar complaint shows the reported issue is a known issue however the root cause is specific to each individual case.No further action is needed based on the risk acceptance.This issue will be tracked and trended in the monthly complaint trend review meetings.

• Brand Name: MONARCH PLATFORM
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES
• Manufacturer (Section D): AURIS HEALTH, INC.; 150 shoreline drive; redwood city CA 94065
• Manufacturer (Section G): AURIS HEALTH, INC.; 150 shoreline drive; redwood city CA
• Manufacturer Contact: monica nachbar ; 150 shoreline drive; redwood city 94065 ; 6502085208
• MDR Report Key: 17703360
• Report Number: 3014447948-2023-00021
• Device Sequence Number: 20694535
• Product Code: EOQ
• UDI-Device Identifier: B634MON000005010
• UDI-Public: +B634MON000005010/16D20210922
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K211493
• 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): 09/07/2023

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 Model Number: MON-000006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown