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

Model Number	MON-000005-01
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a monarch bronchoscopy procedure a 500-29-0-310 idm torque mismatch fault was reported.The physician was at the target, and was readjusting to place a fiducial, when the fault occurred.The account manager powered down the system and attempted to restart, however, the fault persisted when the arms were un-stowed.The physician swapped to a second scope the issue continued.The physician elected to abort the case, which is to be rescheduled.There were no reported adverse effects to the patient because of the system issues.
Additional Manufacturer Narrative
Auris failure analysis engineering reviewed the logs and confirmed the reported fault 500-29-0-310 ¿idm torque mismatch¿.This was reported by robotic arm 1 (id29), idm output shaft 0 (index0).This fault is reported when the torque value mismatch with the torque approximation from the current of more than 0.5 nm.The arm was tested in-house on a system level, and during arm deployment, the arm reported the same fault.The telemetry logs shows the current was not proportional to the torque, specially that fault is being triggered during arm deployment when the output shaft is not used beside while driving the system.The subject arm was returned to the original equipment manufacturer (oem) kinova, for further investigation.Upon their testing, the issue was reproduced, and root cause determined to be due to a chip failure on the driver board (u5), where the reference voltage supplied by the chip u5 is wrong.Reviewing the complaint investigations history for this failure, it revealed this is the first failure for this u5 chip reporting the torque mis-match fault and therefore considered an isolated event and random component failure.Reported issue was confirmed and cause was traced to driver board u5 chip failure.Component code: g02013.Medical device problem code: a07.Type of investigation: b24, b01, b11.Investigation finding: c0201.Investigation conclusions: d02.

• 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: harminder kaur ; 150 shoreline drive; redwood city, CA 94065 ; 5106057113
• MDR Report Key: 16538428
• Report Number: 3014447948-2023-00011
• Device Sequence Number: 5945948
• Product Code: EOQ
• UDI-Device Identifier: B634MON000005010
• UDI-Public: +B634MON000005010/16D20201112
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MON-000005-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2020
• 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