CMR Surgical Versius: hand-controller arm went still and console became unrecoverable, forcing open conversion (FDA MAUDE)
[MALFUNCTION]Apr 7, 2026 · CMR Surgical · Versius · India
Failure Mode
MALFUNCTION
Event Date
Apr 7, 2026
Primary Entity
CMR Surgical
Robotic Platform
Versius
Jurisdiction / Location
India
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
An FDA MAUDE injury report describes a CMR Surgical Versius right-hand controller arm going still with the console unrecoverable, forcing conversion to open surgery. CMR disputed a device defect and noted the patient's BMI was outside the indicated range. Source: FDA MAUDE MDR report 3015488559-2026-00018, accessdata.fda.gov; openFDA device event (brand Versius).
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
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Details
Incident Context & FAQ
What happened in CMR Surgical Versius: hand-controller arm went still and console became unrecoverable, forcing open conversion (FDA MAUDE)?
An FDA MAUDE injury report describes a CMR Surgical Versius right-hand controller arm going still with the console unrecoverable, forcing conversion to open surgery. CMR disputed a device defect and noted the patient's BMI was outside the indicated range. Source: FDA MAUDE MDR report 3015488559-2026-00018, accessdata.fda.gov; openFDA device event (brand Versius).
When did this incident occur?
The incident is recorded as occurring on April 7, 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 CMR Surgical Versius: hand-controller arm went still and console became unrecoverable, forcing open conversion (FDA MAUDE)?
Versius by CMR Surgical is the recorded robot involved in this incident at India.
Has anyone responded to CMR Surgical Versius: hand-controller arm went still and console became unrecoverable, forcing 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 CMR Surgical Versius: hand-controller arm went still and console became unrecoverable, forcing open conversion (FDA MAUDE)?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.