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 06/29/2022

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 bronchoscopy procedure.During that procedure the monarch system reported having fault 500-29-4-217 actuator torque sampling rate fault.The account manager (am) reported that the customer power cycled the system 5 times but was unable to clear the fault to log in or begin system setup.Biomed followed up with a call and confirmed the error.Fault id 500-29-4-217 comes up right after login screen is displayed on the tower monitor and clicking from the cart was heard.However, because of the issue, the physician elected to abort the case.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The reported event was confirmed.500-29-4-217, is a firmware (fw) level fault reported by robotic arm 1 (id29) on actuator 4 (index 0), the 217 fault is an actuator torque sampling rate, that is being triggered when not all 4 channels (strain gauges) sampled at least once within the limit specified (2ms).Auris received the subject robotic arm sn (b)(6) on (b)(6) 2022.The subject robotic arm assembly was returned to the original equipment manufacturer (oem) ¿ kinova.Kinova has performed their investigation on the arm and were able to reproduce the reported issue on j5.However, a definitive root cause could not be established.

• 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: 15135008
• MDR Text Key: 304723525
• Report Number: 3014447948-2022-00020
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: B634MON0000060
• UDI-Public: +B634MON0000060/16D20210913
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2021
• 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