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 01/04/2023

Event Type  malfunction  

Event Description

It was reported that during a monarch bronchoscopy procedure, the physician reported encountering a 1205-50-0 navigation fault and the navigation was inaccurate.As the scope was moved, the distance to the target would not change.The physician chose to abort the procedure.There were no reported adverse effects to the patient because of the system issues.

Manufacturer Narrative

Engineering confirmed that the logs of the reported event were not being uploaded to the cloud.Three good faith efforts (gfe) were made acquiring the logs.However, the logs have not become available as of 2/15/2023 (see support request 00062784).Due to the absence of logs, engineering is unable to confirm the occurrence of this fault and a full failure analysis cannot be performed.The root cause cannot be determined based on the information provided.As the failure cannot be confirmed and no root cause can be identified, this record cannot be linked to any existing modefs or fmea line items related to the reported issue.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.The scope in the case were examined and a review of the calibration data obtained from production final acceptance testing revealed all acceptance criteria were met and no anomalies found.Based on the results from the examination, the product met specifications.A review of similar investigations with similar reported issue (em error) has noted that this is a known issue and have not established a possible root cause.This issue will be tracked and trended in the monthly complaint 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 94065
• Manufacturer Contact: andria smith ; 150 shoreline drive; redwood city, CA 94065 ; 574551-067
• MDR Report Key: 16130809
• MDR Text Key: 308749825
• Report Number: 3014447948-2023-00002
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: B634MON0000060
• UDI-Public: +B634MON0000060/16D20210122
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• 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: 02/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1