FDA Adverse Event Malfunction Summary report: N

MONARCH BRONCHOSCOPE

MDR report key: 23644223 · Received November 25, 2025

Report

Report Number
23644223
Event Type
Malfunction
Date Received
November 25, 2025
Date of Event
September 4, 2025
Report Date
September 24, 2025
Manufacturer
AURIS HEALTH, INC.
Product Code
EOQ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA
Reporter Occupation
RISK MANAGER
Health Professional
N

Narratives

Description of Event or Problem · 0

FOLLOWING SUCCESSFUL INTUBATION, THE INSPECTION PHASE OF THE PROCEDURE WAS COMPLETED USING OLYMPUS BRONCHOSCOPE. THE MONARCH ROBOT ARMS WERE ALIGNED WITH THE PT INTRODUCER BY MD AND TWO OTHERS. THE MONARCH BRONCHOSCOPE WAS THEN ATTACHED, AND THE SYSTEM BEGAN ITS NORMAL TENSIONING PROCESS. UPON SECURING THE SCOPE TO THE ALIGNED ROBOTIC ARMS, A TENSIONING ERROR OCCURRED. THE SCOPE WAS REMOVED AND REATTACHED TO ATTEMPT TO RESOLVE THE ISSUE. DURING RETENSIONING, THE SYSTEM FAILED TO RECOGNIZE THE SHEATH PORTION OF THE BRONCHOSCOPE. AN ERROR MSG [MESSAGE] APPEARED ON THE SCREEN: "FAULT ID 500-20-5-307, ROBOT CONTROLLER ERROR, A SYSTEM ERROR OCCURRED. ALL ROBOTIC FUNCTIONS HAVE BEEN DISABLED. TO RESOLVE, UNLOAD THEN RELOAD THE BRONCHOSCOPE AND CLICK OK TO ACKNOWLEDGE THE FAULT. THEN, RE-INITIALIZE NAVIGATION AT THE MAIN CARINA." ATTEMPTS WERE MADE TO STOW ROBOTIC ARMS, BUT STOWING PROCESS FROZE, AND ARMS FAILED TO COMPLETE THE OPERATION. RESULTED IN A DELAY OF CARE. MANUFACTURER RESPONSE FOR MONARCH RAB SYATEM, JOHNSON AND JOHNSON MONARCH (PER SITE REPORTER). UNKNOWN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2715550 MONARCH BRONCHOSCOPE BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ AURIS HEALTH, INC.

Patients

Seq Age Sex Outcome Treatment
1 67 YR Unknown