{"id":"c8a5d018-01bf-42bd-a140-f74e612f5ff1","slug":"fatality-2023-11-10-quantum-surgical","kind":"fatality","headline":"Patient death during Epione-assisted liver cancer ablation procedure in France","summary":"A 70-year-old male patient treated for liver cancer by irreversible electroporation (IRE) with the Epione device to place 6 needles experienced severe abdominal bleeding at the end of the intervention. The patient underwent artery embolization and blood transfusion but subsequently died. The manufacturer's investigation found no device malfunction; the root cause was attributed to planned needle trajectories being too close to or crossing critical vascular structures, compounded by absence of intermediate control CT scans as recommended in the user manual.","occurredAt":"2023-11-10T12:00:00.000Z","reviewStatus":"unreviewed","modelId":"ba28973f-6a33-4cce-a22f-d34a99443937","deploymentId":null,"companyId":"cb6a0ecc-6b4d-486d-9356-ea9c928ba0ed","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"critical","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":null,"regulatoryAction":"inquiry_opened","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":null,"createdAt":"2026-07-06T15:05:32.874Z","updatedAt":"2026-07-06T15:05:32.874Z","model":{"id":"ba28973f-6a33-4cce-a22f-d34a99443937","companyId":"cb6a0ecc-6b4d-486d-9356-ea9c928ba0ed","modelName":"Epione","slug":"epione","description":"","formFactor":"surgical","maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"specs":{},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.quantumsurgical.com/news/fda-clears-quantum-surgicals-epione-robot-for-all-abdominal-cancers","title":"FDA clears Quantum Surgical's Epione robot for all abdominal cancers","sourceName":"Quantum Surgical"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"keyFacts":[],"createdAt":"2026-07-06T14:11:34.647Z","updatedAt":"2026-07-06T15:24:11.085Z"},"deployment":null,"company":{"id":"cb6a0ecc-6b4d-486d-9356-ea9c928ba0ed","name":"Quantum Surgical","slug":"quantum-surgical","description":"French medical robotics company developing the [Epione](/models/epione) robotic platform for CT-guided percutaneous tumor ablation, enabling minimally invasive treatment of abdominal, lung, and bone cancers. Founded in 2017 by a team of former [Medtech SA](/companies/medtech-sa) engineers led by Bertin Nahum, the company is headquartered in Montpellier with a US subsidiary in Miami. Now part of Precision IO Group after acquiring NeuWave Medical in February 2026, with over 1,400 patients treated across Europe and the United States.","status":null,"founded":2017,"hq":"Montpellier, France","fundingTotal":"86923000","type":"hardware","reviewStatus":"reviewed","sources":[{"url":"https://www.quantumsurgical.com/news/fda-clears-quantum-surgicals-epione-robot-for-all-abdominal-cancers","title":"FDA clears Quantum Surgical's Epione robot for all abdominal cancers","sourceName":"Quantum Surgical"}],"keyFacts":[{"label":"FDA cleared","value":"abdominal ablation indication"},{"label":"CE marked","value":"abdomen, chest, musculoskeletal"},{"label":"Acquired NeuWave Medical","value":"Feb 2026"},{"label":"CEO","value":"Bertin Nahum (President & Co-founder)"},{"label":"Group CEO","value":"Kurt Azarbarzin (Precision IO Group, appointed Feb 2026)"},{"label":"Co-founders","value":"Bertin Nahum, Fernand Badano, Lucien Blondel, Sophie Roca"},{"label":"Total funding","value":"approx 90M USD (50M EUR equity + 30M EUR EIB loan)"},{"label":"FDA clearance","value":"510(k) K223758 for abdominal tumor ablation"},{"label":"CE mark","value":"abdomen, lung, and musculoskeletal indications"},{"label":"Parent company","value":"Precision IO Group Inc. (since Feb 2026)"},{"label":"Patients treated","value":"1400+ (as of 2026)"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"createdAt":"2026-07-06T14:11:34.262Z","updatedAt":"2026-07-06T15:24:10.692Z"},"derived":{"status":"active"},"sources":[{"id":"6cc2947c-cc34-4a36-b70d-695d4749c4ef","incidentId":"c8a5d018-01bf-42bd-a140-f74e612f5ff1","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=18290630&pc=JAK","label":null,"publishedAt":null,"notes":null,"title":"MAUDE Adverse Event Report: QUANTUM SURGICAL SAS EPIONE","sourceName":"FDA MAUDE Database","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-06T15:05:33.259Z","updatedAt":"2026-07-06T15:05:33.259Z"}],"responses":[],"statusEvents":[{"id":"69a4c602-6731-48b7-b2df-d32ea966de08","incidentId":"c8a5d018-01bf-42bd-a140-f74e612f5ff1","status":"active","reason":null,"source":"agent:depth","effectiveAt":"2026-07-06T15:05:33.647Z","createdAt":"2026-07-06T15:05:33.648Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/fatality-2023-11-10-quantum-surgical","url":"https://registry.deploy.report/incidents/fatality-2023-11-10-quantum-surgical","headline":"Patient death during Epione-assisted liver cancer ablation procedure in France","description":"A 70-year-old male patient treated for liver cancer by irreversible electroporation (IRE) with the Epione device to place 6 needles experienced severe abdominal bleeding at the end of the intervention. The patient underwent artery embolization and blood transfusion but subsequently died. The manufacturer's investigation found no device malfunction; the root cause was attributed to planned needle trajectories being too close to or crossing critical vascular structures, compounded by absence of intermediate control CT scans as recommended in the user manual.","identifier":"c8a5d018-01bf-42bd-a140-f74e612f5ff1","datePublished":"2023-11-10T12:00:00.000Z","articleSection":"fatality","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":1,"primary_source_types":["primary-fda-database"]}}}