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

Model Number MON-000006

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/17/2022

Event Type  malfunction  

Event Description

It was reported at start-up when commanding the arms to unstow, the customer experienced 1403-50-0-0 ethercat fault followed by 804 e-stop fault.This occurred upon multiple reboots and attempts.The physician aborted case, switched to manual scope but the target was too far so the case was not completed.

Manufacturer Narrative

The risk of a prolonged or delayed procedure is documented in 105-000363-00, rev h, dfmea arms & idms, platform 2.A review of the usage logs source s3: studydata/2022-08-17/system120102_man/{8c858405-765a-4bdd-84c0-8aeea32549ce} confirmed the reported issue of customer experiencing multiple 1403 faults.A 1403 fault indicates a ethercat communication fault.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.As indicated in the sr, the fse was not able to replicate the fault.As such, a cause could not be determined.

• 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 94065
• Manufacturer Contact: andria smith ; 150 shoreline drive; redwood city, CA 94065 ; 574551-067
• MDR Report Key: 15411111
• MDR Text Key: 305831413
• Report Number: 3014447948-2022-00030
• 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): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• 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: 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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