Auris Monarch bronchoscope: Navigation EM error at the docking station, scope removed (FDA MAUDE)
[MALFUNCTION]May 8, 2026 · Auris Health · Monarch Platform · Surgical robots
Failure Mode
MALFUNCTION
Event Date
May 8, 2026
Primary Entity
Auris Health
Robotic Platform
Monarch Platform
Jurisdiction / Location
Surgical robots
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
An FDA MAUDE malfunction report describes an Auris Monarch bronchoscope displaying a Navigation EM error when connected to the docking station, leading to the scope being removed. Source: FDA MAUDE MDR key 25229150, openFDA device event / accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=25229150&pc=EOQ
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=25229150&pc=EOQ
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Details
Incident Context & FAQ
What happened in Auris Monarch bronchoscope: Navigation EM error at the docking station, scope removed (FDA MAUDE)?
An FDA MAUDE malfunction report describes an Auris Monarch bronchoscope displaying a Navigation EM error when connected to the docking station, leading to the scope being removed. Source: FDA MAUDE MDR key 25229150, openFDA device event / accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.
When did this incident occur?
The incident is recorded as occurring on May 8, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Auris Monarch bronchoscope: Navigation EM error at the docking station, scope removed (FDA MAUDE)?
Monarch Platform by Auris Health is the recorded robot involved in this incident.
Has anyone responded to Auris Monarch bronchoscope: Navigation EM error at the docking station, scope removed (FDA MAUDE)?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of Auris Monarch bronchoscope: Navigation EM error at the docking station, scope removed (FDA MAUDE)?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.