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

Model Number	MON-000005-01
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported issue of joint actual velocity and position contradict, cart disconnected faults and showing ethercat initialization failure fault was confirmed via the supplied picture from the account manager.Although the photographic evidence confirms the reported issue, it is likely the joint actual velocity and position contradict fault was thrown first and the cart disconnected and ethercat faults were thrown when the system was disconnected to troubleshoot and umbilical cable unplugged to be inspected.However, this cannot be confirmed.
Event or Problem Description
It was reported that during the monarch bronchoscopy procedure they were trying to un-stow the arms and received faults.The physician elected to abort the case and reschedule for a later date.There was no report of an adverse event due to system issues.

• 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 94065
• Manufacturer Contact: harminder kaur ; 150 shoreline drive; redwood city, CA 94065 ; 6282544750
• MDR Report Key: 20539444
• Report Number: 3014447948-2024-00023
• Device Sequence Number: 15524984
• Product Code: EOQ
• UDI-Device Identifier: B634MON000005010
• UDI-Public: +B634MON000005010/16D20210831
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K231473
• 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 Assistant
• Type of Report: Initial
• Report Date (Section B): 10/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MON-000005-01
• 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: 09/27/2024
• Initial Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown