Medtronic Hugo RAS: robotic arm froze during undocking, leading to bleeding and open conversion (FDA MAUDE)
[MALFUNCTION]Jan 16, 2026 · Medtronic · Hugo RAS · Dublin, Ireland
Failure Mode
MALFUNCTION
Event Date
Jan 16, 2026
Primary Entity
Medtronic
Robotic Platform
Hugo RAS
Jurisdiction / Location
Dublin, Ireland
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
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.
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.massdevice.com/medtronic-safety-notice-hugo-robot-console/
https://www.massdevice.com/medtronic-safety-notice-hugo-robot-console/
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Details
Incident Context & FAQ
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.
What robot was involved in Medtronic Hugo RAS: robotic arm froze during undocking, leading to bleeding and open conversion (FDA MAUDE)?
Hugo RAS by Medtronic is the recorded robot involved in this incident at Dublin, Ireland.
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.