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Incident · Malfunction

Medtronic Hugo RAS: robotic arm froze during undocking, leading to bleeding and open conversion (FDA MAUDE)

An FDA MAUDE injury report describes a Medtronic Hugo RAS arm freezing during undocking, causing strong bleeding that forced conversion to open surgery with a transfusion. One of several early Hugo console/arm malfunction reports after the system's Dec 2025 US urologic clearance. Source: FDA MAUDE MDR key 23929871, accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.

Occurred 2026-01-16 · Medtronic · 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 Medtronic Hugo RAS: robotic arm froze during undocking, leading to bleeding and open conversion (FDA MAUDE)

Machine-readable surfaces

Sources (2)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
  2. https://www.massdevice.com/medtronic-safety-notice-hugo-robot-console/

Common questions

What happened in Medtronic Hugo RAS: robotic arm froze during undocking, leading to bleeding and open conversion (FDA MAUDE)?
An FDA MAUDE injury report describes a Medtronic Hugo RAS arm freezing during undocking, causing strong bleeding that forced conversion to open surgery with a transfusion. One of several early Hugo console/arm malfunction reports after the system's Dec 2025 US urologic clearance. Source: FDA MAUDE MDR key 23929871, accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.
When did this incident occur?
The incident is recorded as occurring on January 16, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
Who was involved in Medtronic Hugo RAS: robotic arm froze during undocking, leading to bleeding and open conversion (FDA MAUDE)?
The incident is recorded as involving Medtronic on the DEPLOY registry. No specific robot model is linked to this incident in the registry.
Has anyone responded to Medtronic Hugo RAS: robotic arm froze during undocking, leading to bleeding and open conversion (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 Medtronic Hugo RAS: robotic arm froze during undocking, leading to bleeding and open conversion (FDA MAUDE)?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 2 sources (1 primary) · last reviewed 2026-08-09

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-09

Sources by quality tier

1
primary-fda-database
FDA database
1
unclassified
Unclassified source

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

Methodology surface for Medtronic Hugo RAS: robotic arm froze during undocking, leading to bleeding and open conversion (FDA MAUDE).

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Canonical ID 3da410c6-cd9e-4167-bff7-4566a81d78dd