{"id":"5ee1871a-3b83-4056-a9d3-7048c272c175","slug":"auris-monarch-bronchoscope-navigation-em-error-maude-2026","kind":"malfunction","headline":"Auris Monarch bronchoscope: Navigation EM error at the docking station, scope removed (FDA MAUDE)","summary":"An FDA MAUDE malfunction report describes an Auris Monarch bronchoscope displaying a Navigation EM error when connected to the docking station, leading to the scope being removed. Source: FDA MAUDE MDR key 25229150, openFDA device event / accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.","occurredAt":"2026-05-08T00:00:00.000Z","reviewStatus":"reviewed","modelId":"fec634ea-8227-4fba-8acc-695f3728a469","deploymentId":null,"companyId":"df69ac5c-53c1-4fa6-94d2-8f377e9bf87c","dataCenterId":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"moderate","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":"2026-06-27T11:10:34.471Z","updatedAt":"2026-08-09T05:29:22.113Z","model":{"id":"fec634ea-8227-4fba-8acc-695f3728a469","companyId":"df69ac5c-53c1-4fa6-94d2-8f377e9bf87c","modelName":"Monarch Platform","slug":"auris-health-monarch","description":"The Auris Health Monarch Platform is a robotic-assisted bronchoscopy system cleared by the FDA in March 2018, enabling physicians to navigate further into the lung for peripheral pulmonary lesion diagnosis and biopsy than is possible with conventional bronchoscopes. The system uses a 10-DOF bronchoscope-and-sheath design with electromagnetic navigation, an outer sheath of 6.0 mm diameter, an inner scope of 4.4 mm, and a 2.1 mm working channel. Auris Health was acquired by Johnson and Johnson for $3.4 billion in 2019 and the Monarch is now commercialised by J&J MedTech.","formFactor":"surgical","industryVertical":"healthcare","environment":"indoor","maturityStage":"research","lifecycleState":"active","supersededByModelId":null,"specs":{"dof":"10","fda_clearance":"March 2018","clearance_body":"FDA","procedure_types":"bronchoscopy","working_channel_mm":"2.1","inner_scope_diameter_mm":"4.4","outer_sheath_diameter_mm":"6.0"},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.jnjmedtech.com/en-US/products/robotics/monarch-platform/bronchoscopy/","label":"MONARCH Platform | J&J MedTech US","title":"MONARCH Platform | J&J MedTech US","mediaType":"article"},{"url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC7330790/","label":"Robotic bronchoscopy for pulmonary lesions - PMC","title":"Robotic bronchoscopy for pulmonary lesions - PMC","mediaType":"article"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"keyFacts":[{"label":"DOF","value":"10"},{"label":"Outer sheath diameter","value":"6.0 mm"},{"label":"Inner scope diameter","value":"4.4 mm"},{"label":"Working channel","value":"2.1 mm"},{"label":"FDA clearance date","value":"March 2018"}],"createdAt":"2026-06-27T21:36:19.984Z","updatedAt":"2026-07-12T04:24:54.291Z","unitsInFieldClaimed":null,"unitsInFieldVerified":null,"unitsManufacturedClaimed":null,"unitsManufacturedVerified":null,"unitsAsOf":null,"unitsSource":null,"salesModel":null,"priceUndisclosedSince":null,"autonomyClass":null,"autonomyStatement":null,"autonomyStatementSource":null,"demoForensics":null,"exportControlClass":null,"minCommitment":null,"warrantyTerms":null,"serviceModel":null,"productionRateClaimed":null,"productionRateEvidenced":null,"teleopRatioDisclosed":null,"interventionRateDisclosed":null},"deployment":null,"company":{"id":"df69ac5c-53c1-4fa6-94d2-8f377e9bf87c","name":"Auris Health","slug":"auris-health","description":"American surgical robotics company developing the Monarch Platform for robotic-assisted bronchoscopy. Founded by Frederic Moll (also founder of [Intuitive surgical](/companies/intuitive-surgical)). Acquired by Johnson & Johnson for $3.4B in 2019, now part of J&J MedTech.","status":"subsidiary","founded":2007,"hq":"Redwood City, California, USA","hqLat":37.4863239,"hqLng":-122.232523,"hqGeocodedAt":"2026-08-05T14:20:33.479Z","hqAddress":null,"hqPrecision":null,"website":"aurishealth.com","fundingTotal":null,"type":"hardware","roles":["robot_maker"],"reviewStatus":"reviewed","heatIndex":50,"lifecycleState":"active","supersededByCompanyId":null,"sources":[{"url":"https://techcrunch.com/2019/02/13/jj-spends-3-4-billion-in-cash-for-auris-healths-lung-cancer-diagnostics-and-surgical-robots/","title":"J&J acquires Auris Health for $3.4B","date_accessed":"2026-06-23"}],"keyFacts":[{"label":"Founder","value":"Frederic Moll (also founded Intuitive Surgical)"},{"label":"HQ","value":"Redwood City, California, USA"},{"label":"Founded","value":"2007 (as Auris Surgical Robots)"},{"label":"Acquisition","value":"Acquired by Johnson & Johnson for $3.4B in February 2019 — now part of J&J MedTech"},{"label":"Product","value":"Monarch Platform — first flexible robotically-assisted platform for bronchoscopy"},{"label":"FDA clearance","value":"Monarch Platform FDA-cleared for robotic-assisted bronchoscopy (2018)"},{"label":"Monarch Quest","value":"FDA cleared Monarch Quest for enhanced robotic-assisted bronchoscopy (2025)"},{"label":"Incidents","value":"7 incidents on file — already recorded in registry"}],"aliases":[],"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":"2026-06-24T01:51:54.280Z","updatedAt":"2026-08-21T22:28:54.393Z"},"derived":{"status":"active"},"sources":[{"id":"9c3e45b2-a60c-43d5-b2f5-3bb1c8402083","incidentId":"5ee1871a-3b83-4056-a9d3-7048c272c175","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm","label":null,"publishedAt":null,"notes":null,"title":"FDA MAUDE: Auris Monarch bronchoscope navigation EM error","sourceName":"FDA MAUDE","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-08-09T05:28:24.219Z","updatedAt":"2026-08-09T05:28:24.219Z"},{"id":"f1a6ea6c-a86a-4484-a322-859e11115da7","incidentId":"5ee1871a-3b83-4056-a9d3-7048c272c175","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=25229150&pc=EOQ","label":null,"publishedAt":null,"notes":null,"title":"MAUDE Adverse Event Report: AURIS HEALTH, INC. MONARCH - Navigation EM error","sourceName":"FDA MAUDE","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-08-09T05:31:09.008Z","updatedAt":"2026-08-09T05:31:09.008Z"}],"responses":[],"statusEvents":[],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/auris-monarch-bronchoscope-navigation-em-error-maude-2026","url":"https://registry.deploy.report/incidents/auris-monarch-bronchoscope-navigation-em-error-maude-2026","headline":"Auris Monarch bronchoscope: Navigation EM error at the docking station, scope removed (FDA MAUDE)","description":"An FDA MAUDE malfunction report describes an Auris Monarch bronchoscope displaying a Navigation EM error when connected to the docking station, leading to the scope being removed. Source: FDA MAUDE MDR key 25229150, openFDA device event / accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.","identifier":"5ee1871a-3b83-4056-a9d3-7048c272c175","datePublished":"2026-05-08T00:00:00.000Z","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":2,"primary_source_types":["primary-fda-database"]}}}