{"id":"35d4e5d4-14b0-4ceb-a05e-584c67bae427","slug":"cmr-versius-controller-still-open-conversion-maude-2026","kind":"malfunction","headline":"CMR Surgical Versius: hand-controller arm went still and console became unrecoverable, forcing open conversion (FDA MAUDE)","summary":"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).","occurredAt":"2026-04-07T00:00:00.000Z","reviewStatus":"reviewed","modelId":null,"deploymentId":null,"companyId":"6bbb447e-0278-4ae1-822d-8b546420511e","dataCenterId":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"serious","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":null,"regulatoryAction":"none","regulatoryBody":"FDA (MAUDE)","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":2,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"formFactor":null,"latitude":null,"longitude":null,"autonomyClass":null,"legalOutcomeClass":"unknown","createdAt":"2026-06-27T10:59:24.907Z","updatedAt":"2026-08-09T05:29:22.113Z","model":null,"deployment":null,"company":{"id":"6bbb447e-0278-4ae1-822d-8b546420511e","name":"CMR Surgical","slug":"cmr-surgical","description":"UK surgical-robotics company (Cambridge; founded 2014) making the Versius modular multi-arm teleoperated surgical robot; FDA De Novo 2024 + Versius Plus 510(k) 2025; >40k procedures ex-US.","status":"private (recapitalized $200M+ Apr 2025; current valuation unconfirmed)","founded":2014,"hq":"Cambridge, United Kingdom","hqLat":52.1975846,"hqLng":0.1391537,"hqGeocodedAt":"2026-08-05T00:50:46.343Z","hqAddress":null,"hqPrecision":null,"website":"cmrsurgical.com","fundingTotal":null,"type":"both","reviewStatus":"reviewed","lifecycleState":"active","supersededByCompanyId":null,"sources":[{"url":"https://www.globenewswire.com/news-release/2024/10/15/cmr-surgical-versius-fda-de-novo","title":"CMR Surgical receives US FDA De Novo for Versius (cholecystectomy; Oct 2024)","sourceName":"CMR Surgical (GlobeNewswire)"},{"url":"https://www.therobotreport.com/cmr-surgical-receives-fda-clearance-for-versius-plus-surgical-robot/","title":"CMR Surgical FDA 510(k) for Versius Plus (Dec 18 2025; US launch 2026)","sourceName":"The Robot Report"},{"url":"https://www.massdevice.com/cmr-surgical-200-million-funding/","title":"CMR Surgical raises $200M+ to fund US/Asia commercialization (Apr 2025)","sourceName":"MassDevice"},{"url":"https://www.globenewswire.com/news-release/2026/03/17/cmr-surgical-nvidia-igx-thor","title":"CMR Surgical + NVIDIA IGX Thor (evaluating AI for next-gen Versius; R&D-stage)","sourceName":"CMR Surgical (GlobeNewswire)"}],"keyFacts":[{"label":"Product","value":"Versius / Versius Plus modular multi-arm teleoperated surgical robot."},{"label":"Gating events","value":"FDA De Novo Oct 2024; Versius Plus 510(k) Dec 2025; gynecology 510(k) pending."},{"label":"wikidata","value":"https://www.wikidata.org/wiki/Q60775579"},{"label":"wikipedia","value":"https://en.wikipedia.org/wiki/CMR_Surgical"},{"label":"Founded","value":"2014, Cambridge, UK"},{"label":"Key product","value":"Versius surgical robot system"},{"label":"FDA clearance","value":"Versius Plus secured"}],"aliases":["CMR","Cambridge Medical Robotics","Versius"],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"tickerSymbol":null,"stockExchange":null,"secCik":null,"revenueUsd":null,"revenueBasis":null,"revenueAsOf":null,"employeeCount":null,"employeeCountBasis":null,"employeeCountAsOf":null,"marketCapUsd":null,"marketCapAsOf":null,"marketCapSource":null,"createdAt":"2026-06-03T20:12:28.328Z","updatedAt":"2026-08-05T02:17:05.420Z"},"derived":{"status":"active"},"sources":[{"id":"720592ba-f2da-4354-837f-ccac09a48d9f","incidentId":"35d4e5d4-14b0-4ceb-a05e-584c67bae427","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm","label":null,"publishedAt":null,"notes":null,"title":"FDA MAUDE: CMR Surgical Versius controller failure","sourceName":"FDA MAUDE","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-08-09T05:28:25.651Z","updatedAt":"2026-08-09T05:28:25.651Z"}],"responses":[],"statusEvents":[],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/cmr-versius-controller-still-open-conversion-maude-2026","url":"https://registry.deploy.report/incidents/cmr-versius-controller-still-open-conversion-maude-2026","headline":"CMR Surgical Versius: hand-controller arm went still and console became unrecoverable, forcing open conversion (FDA MAUDE)","description":"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).","identifier":"35d4e5d4-14b0-4ceb-a05e-584c67bae427","datePublished":"2026-04-07T00:00:00.000Z","articleSection":"malfunction","publisher":{"@id":"https://deploy.report/#organization"},"author":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"verified","maturity_stage":null,"lifecycle_state":null,"architectural_position":{"cohort":null,"sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":1,"primary_source_types":["primary-fda-database"]}}}