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

Model Number MON-000006

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2022

Event Type  malfunction  

Manufacturer Narrative

The risk of a prolonged or delayed procedure is documented in 105-000363-00, rev h, dfmea arms & idms, platform 2.Based on the available information for this event, the root cause is still undetermined pending investigation.

Event Description

It was reported that the patient underwent a monarch bronchoscope procedure.During that procedure, it was reported the monarch system had multiple 1403-50-0-0 ethercat faults.The physician did not have a backup scope, removed the scope, and aborted the case.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following there was no communication between the ethercat chain and the slave application (two power distribution units, one staging motor, and two robotic arms).This could be due to multiple reasons- umbilical cable between the tower and cart is damaged or not plugged in, firmware defect or hardware defect in one of the slave devices, interplay between hardware and firmware.Hardware malfunction could be introduced by external factors like temperature changes, high frequency noise in the alternating current (ac) input of the power supply.The issue is typically resolved after a hard power cycle is performed.The 1403 fault was followed by an 804 or e-stop fault.Because of the interruption in communication (ethercat) chain between the tower and cart that triggered the 804 e-stop fault.The system normally would need to be rebooted when an 804 fault occurs to resolve the issue.The system behaved as intended.The field service engineer (fse) was not able to replicate the fault.As such, a cause could not be determined.A review for similar report shows this to be a known issue where a cause is specific to each individual case.A review of the device history record (dhr) for the system did not reveal any nonconforming issue that would relate to the reported incident.The incident will continue to be tracked in regular trend review meetings.

• Brand Name: MONARCH PLATFORM
• Type of Device: 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: andria smith ; 150 shoreline drive; redwood city, CA 94065 ; 5745510671
• MDR Report Key: 15282825
• MDR Text Key: 303352270
• Report Number: 3014447948-2022-00025
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: B634MON0000060
• UDI-Public: +B634MON0000060/16D20211102
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193534
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MON-000006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1