Medtronic Hugo RAS: bipolar grasper broke and dropped a resin insulator fragment into a patient (FDA MAUDE)
[INJURY]May 11, 2026 · Medtronic · Hugo RAS · Dublin, Ireland
Failure Mode
INJURY
Event Date
May 11, 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 Bipolar Fenestrated Grasper breaking during a sigmoid colectomy, dropping a resin insulator fragment into the patient. Hugo received FDA urologic clearance Dec 2025; MAUDE reporting began Dec 2025. Source: FDA MAUDE MDR key 25333614, 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?dbid=mdr&productcode=JAK&firmlegalnam=Medtronic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm?dbid=mdr&productcode=JAK&firmlegalnam=Medtronic
- 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 Medtronic Hugo RAS: bipolar grasper broke and dropped a resin insulator fragment into a patient (FDA MAUDE)?
An FDA MAUDE injury report describes a Medtronic Hugo RAS Bipolar Fenestrated Grasper breaking during a sigmoid colectomy, dropping a resin insulator fragment into the patient. Hugo received FDA urologic clearance Dec 2025; MAUDE reporting began Dec 2025. Source: FDA MAUDE MDR key 25333614, accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.
When did this incident occur?
The incident is recorded as occurring on May 11, 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: bipolar grasper broke and dropped a resin insulator fragment into a patient (FDA MAUDE)?
Hugo RAS by Medtronic is the recorded robot involved in this incident at Dublin, Ireland.
Has anyone responded to Medtronic Hugo RAS: bipolar grasper broke and dropped a resin insulator fragment into a patient (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: bipolar grasper broke and dropped a resin insulator fragment into a patient (FDA MAUDE)?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.