Auris Monarch: patient developed pneumothorax post-procedure requiring chest-tube placement (FDA MAUDE)
[INJURY]Apr 30, 2026 · Auris Health · Monarch Platform · Surgical robots
Failure Mode
INJURY
Event Date
Apr 30, 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 injury report describes an Auris Monarch endoscopy platform case in which the patient developed a pneumothorax after the procedure, requiring chest-tube placement. Source: FDA MAUDE MDR key 25166932, 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?dbid=mdr&firmlegalnam=Auris
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm?dbid=mdr&firmlegalnam=Auris
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
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Details
Incident Context & FAQ
What happened in Auris Monarch: patient developed pneumothorax post-procedure requiring chest-tube placement (FDA MAUDE)?
An FDA MAUDE injury report describes an Auris Monarch endoscopy platform case in which the patient developed a pneumothorax after the procedure, requiring chest-tube placement. Source: FDA MAUDE MDR key 25166932, openFDA device event / accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.
When did this incident occur?
The incident is recorded as occurring on April 30, 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: patient developed pneumothorax post-procedure requiring chest-tube placement (FDA MAUDE)?
Monarch Platform by Auris Health is the recorded robot involved in this incident.
Has anyone responded to Auris Monarch: patient developed pneumothorax post-procedure requiring chest-tube placement (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: patient developed pneumothorax post-procedure requiring chest-tube placement (FDA MAUDE)?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.