{"id":"9eae8c01-db66-4c7c-b2af-06e548526897","slug":"medtronic-hugo-grasper-insulator-fragment-maude-2026","kind":"injury","headline":"Medtronic Hugo RAS: bipolar grasper broke and dropped a resin insulator fragment into a patient (FDA MAUDE)","summary":"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.","occurredAt":"2026-05-11T00:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"5ed6adff-c714-4880-bb1e-62af35017f4f","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,"createdAt":"2026-06-27T10:59:24.750Z","updatedAt":"2026-06-27T10:59:24.750Z","model":null,"deployment":null,"company":{"id":"5ed6adff-c714-4880-bb1e-62af35017f4f","name":"Medtronic","slug":"medtronic","description":"Global medical-device company (NYSE: MDT; founded 1949) whose Hugo RAS is the late-market robotic-assisted-surgery challenger to da Vinci; CE-marked 2021, US FDA-cleared for urology Dec 2025.","status":"public (NYSE: MDT)","founded":1949,"hq":"Dublin, Ireland","fundingTotal":null,"type":"both","reviewStatus":"reviewed","sources":[{"url":"https://news.medtronic.com/2025-12-03-Medtronic-announces-FDA-clearance-of-Hugo-TM-robotic-assisted-surgery-system-for-urologic-surgical-procedures","title":"Medtronic: FDA clearance of Hugo RAS for urologic procedures (Dec 3 2025)","sourceName":"Medtronic (official)"},{"url":"https://news.medtronic.com/2021-10-11-Medtronic-Hugo-TM-Robotic-Assisted-Surgery-System-Receives-European-CE-Mark-Approval","title":"Medtronic Hugo RAS receives European CE mark (Oct 11 2021)","sourceName":"Medtronic (official)"},{"url":"https://www.urologytimes.com/view/fda-grants-clearance-to-hugo-robotic-assisted-surgery-system-for-urologic-procedures","title":"FDA grants Hugo RAS clearance for urologic procedures (Expand URO trial)","sourceName":"Urology Times"}],"keyFacts":[{"label":"Product","value":"Hugo RAS modular multi-port teleoperated surgical robot."},{"label":"Gating events","value":"CE mark Oct 2021; US FDA urology clearance Dec 3 2025 (urology only)."},{"label":"Stock listing","value":"NYSE: MDT"},{"label":"Company type","value":"Global medical-device company"},{"label":"Market positioning","value":"Hugo RAS is positioned as a late-market challenger to da Vinci in robotic-assisted surgery"}],"aliases":["Medtronic plc","MDT"],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"createdAt":"2026-06-03T20:12:08.624Z","updatedAt":"2026-06-28T13:52:16.409Z"},"derived":{"status":"active"},"sources":[],"responses":[],"statusEvents":[],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/medtronic-hugo-grasper-insulator-fragment-maude-2026","url":"https://registry.deploy.report/incidents/medtronic-hugo-grasper-insulator-fragment-maude-2026","headline":"Medtronic Hugo RAS: bipolar grasper broke and dropped a resin insulator fragment into a patient (FDA MAUDE)","description":"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.","identifier":"9eae8c01-db66-4c7c-b2af-06e548526897","datePublished":"2026-05-11T00:00:00.000Z","articleSection":"injury","publisher":{"@id":"https://deploy.report/#organization"},"author":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"unreviewed","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":0,"primary_source_types":[]}}}