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

Model Number	MON-000005-01
Medical Device Problem Codes	No Display/Image (1183); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a monarch bronchoscopy procedure, the physician encountered a scope disconnected fault while taking biopsies.As a result of the scope disconnected fault condition, the system provides the following message to the user: ¿warning: the bronchoscope cable has been disconnected.Live bronchoscope view and the system has been halted to prevent patient injury.Reconnect the cable and press ok to continue¿ the hospital staff disconnected and reconnected the cable, but the live video feed was not reestablished.The physician chose to abort the procedure.
Additional Manufacturer Narrative
The reported issue occurred on a device used for diagnosis and not treatment.The scope associated with the reported issue was returned and investigated under (b)(4).The program development manager (pdm) confirmed that even though the customer reported receiving the ¿scope disconnected warning¿ that indicates the scope had been unplugged, the scope was not unplugged from the system during the whole procedure.Failure analysis was unable to confirm the occurrence of any faults or errors related to the reported issue because at the time of this report, the system logs were not available for review.There were multiple attempts to retrieve logs with no success.Although the customer attempted to troubleshoot the issue by disconnecting and reconnecting the scope in use, the customer opted to discontinue the procedure and aborted the case.There were no other faults or errors reported by the customer that would indicate that there was an issue with the system.Based on the available information, the product met specifications.A review of the device history record (dhr) for system 110044 was performed and no non-conformances were identified relating to the reported issue.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 scope tip was manually articulated while monitoring the resistance of each sensor, and the camera image to confirm that there was no intermittent open on either sensor or camera image degradation.The results showed observed both sensors to be within specification, there was a short to the camera gnd wire and camera image was working as expected with led light.The results showed the bronchoscope to be not operating as expected.A review of the calibration data obtained from production final acceptance testing revealed all acceptance criteria were met and no anomalies found.Based on the results from the examination, the product did not meet specifications.A review of similar investigations with similar reported issue (color bar) has noted that this is a known issue and have not established a possible root cause.Previous report submission date: 2/23/2023.Component code: g05001 (scope) , g07002 (system).Investigation findings: c20 (system); investigation conclusion: d14 (system).
Additional Manufacturer Narrative
Engineering performed a visual, functional and electrical investigation of the returned monarch bronchoscope.Engineering determined that there was an electrical short to the camera ground wire.The results showed the bronchoscope to be not operating as expected.Based on the results from the examination, the monarch bronchoscope, a component of the monarch platform, did not be operating as expected.A review of the calibration data obtained from production final acceptance testing of the monarch bronchoscope revealed all acceptance criteria were originally met and no anomalies found.

• 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: monica nachbar ; 150 shoreline drive; redwood city, CA ; 6502085208
• MDR Report Key: 16431595
• Report Number: 3014447948-2023-00005
• Device Sequence Number: 14764012
• 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,Followup
• Report Date (Section B): 03/25/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 01/25/2023; 01/25/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 03/24/2023; 03/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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