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

Model Number MON-000006

Device Problems Computer Software Problem (1112); Appropriate Term/Code Not Available (3191)

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

Event Date 12/13/2022

Event Type  malfunction  

Event Description

It was reported that during a monarch bronchoscopy procedure the physician experienced ¿jumpy navigation¿ when navigating in the inferior portion of the lungs, as well as throughout the case.The physician chose to abort the procedure.There were no reported adverse effects to the patient because of the system navigation issues.

Manufacturer Narrative

There are 6 runs in this case, and 4 of them (run 2, 3, 4, and 5) contain driving.Run 2, 3 and 4 exhibit jumpy inaccuracy between rb6 and lower lobe bronchus due to initially/adaptively registered em being in between branches.The main contributors of the misalignment of em data are ct-body divergence in right lower lobe (likely due to breath-hold during scan vs.No breath hold during procedure) as indicated, posterior articulation and large anterior-posterior respiration motion.Run 5 is less jumpy because of less sheath articulation; however, off-skeleton em in the same direction as the other runs is seen due to ct-body divergence.Minimizing articulation could help reduce the navigation inaccuracy seen in this case.The root cause of the reported issue was due to off-skeleton em data.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.

• 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: 16122519
• MDR Text Key: 308257500
• Report Number: 3014447948-2022-00043
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: B634MON0000060
• UDI-Public: +B634MON0000060/16D20210519
• 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
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• 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: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2021
• 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