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Incident · Injury

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.

Occurred 2026-04-30 · Auris Health · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
Track Auris Monarch: patient developed pneumothorax post-procedure requiring chest-tube placement (FDA MAUDE)

Machine-readable surfaces

Sources (2)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm?dbid=mdr&firmlegalnam=Auris
  2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

Common questions

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.
Who was involved in Auris Monarch: patient developed pneumothorax post-procedure requiring chest-tube placement (FDA MAUDE)?
The incident is recorded as involving Auris Health on the DEPLOY registry. No specific robot model is linked to this incident in the registry.
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.
Methodology: Verified · 2 sources (2 primary) · last reviewed 2026-08-09

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-09

Sources by quality tier

2
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Auris Monarch: patient developed pneumothorax post-procedure requiring chest-tube placement (FDA MAUDE).

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Canonical ID e9497f9d-30c5-4dd4-bdfb-e1f11ae1e102