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

Model Number MON-000006

Device Problems Appropriate Term/Code Not Available (3191); Program or Algorithm Execution Problem (4033)

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

Event Date 12/30/2022

Event Type  malfunction  

Event Description

It was reported that during a monarch bronchoscopy procedure, the physician encountered a navigation initialization error.After approaching the main carina, the physician pressed the set button on the controller and the error occurred.After repeatedly encountering the same error, the physician chose to abort the procedure.There were no reported adverse effects to the patient because of the system error codes.The initial investigation in the field showed an issue with the set button on the controller.The controller was replaced at the site.Systems check passed all tests with the new controller.

Manufacturer Narrative

Two (2) bronchoscopes underwent visual examination, functional testing (mechanical and electrical) and a review of calibration data.Results showed no signs of damage and the product continued to meet specifications.One (1) controller underwent visual inspection and functional testing (mechanical and electrical).The set button of the controller was concluded as not the root cause of the reported issue.The system navigation initialization error code was reviewed.This fault code is a minor system error that would be triggered when initial retraction distance is less than 20 mm or greater than 60 mm.A tracheostomy tube is seen in the region of the pre-op computerized tomography (ct) scan being used in this case, causing only 18.3 mm of the trachea to be segmented.It was confirmed that the root cause of the navigation initialization error was the improper computerized tomography (ct) scan parameters due to user error.A review of the device history record (dhr) was performed.There are no reports of nonconformance that relate to the reported incident.A review for similar complaint shows the reported issue is a known issue however the root cause is specific to each individual case.No further action is needed based on the risk acceptance.This issue will be tracked and trended in the monthly complaint trend review meetings.D1: monarch platform.

• 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: monica nachbar ; 150 shoreline drive; redwood city, CA 94065 ; 6502085208
• MDR Report Key: 16254216
• MDR Text Key: 309193588
• Report Number: 3014447948-2023-00004
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: B634MON0000060
• UDI-Public: +B634MON0000060/16D20211011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: Yes
• 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: 03/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/11/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other