Medtronic Hugo RAS: failure to calibrate with the application program freezing or failing to launch (FDA MAUDE)
[MALFUNCTION]May 21, 2026 · Medtronic · Hugo RAS · Dublin, Ireland
Failure Mode
MALFUNCTION
Event Date
May 21, 2026
Primary Entity
Medtronic
Robotic Platform
Hugo RAS
Jurisdiction / Location
Dublin, Ireland
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
An FDA MAUDE malfunction report describes a Medtronic Hugo RAS failure to calibrate during which the application program froze or failed to launch. Source: FDA MAUDE MDR key 25333336, openFDA device event / accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.
System & Fleet Architecture
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=21344374&pc=GCJ
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=21344374&pc=GCJ
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Details
Incident Context & FAQ
What happened in Medtronic Hugo RAS: failure to calibrate with the application program freezing or failing to launch (FDA MAUDE)?
An FDA MAUDE malfunction report describes a Medtronic Hugo RAS failure to calibrate during which the application program froze or failed to launch. Source: FDA MAUDE MDR key 25333336, openFDA device event / accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.
When did this incident occur?
The incident is recorded as occurring on May 21, 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: failure to calibrate with the application program freezing or failing to launch (FDA MAUDE)?
Hugo RAS by Medtronic is the recorded robot involved in this incident at Dublin, Ireland.
Has anyone responded to Medtronic Hugo RAS: failure to calibrate with the application program freezing or failing to launch (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: failure to calibrate with the application program freezing or failing to launch (FDA MAUDE)?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.