When did this incident occur?

The incident is recorded as occurring on November 10, 2023 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.

Incident · Fatality

Patient death during Epione-assisted liver cancer ablation procedure in France

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.

Occurred 2023-11-10 · Epione · Quantum Surgical

Track Patient death during Epione-assisted liver cancer ablation procedure in France

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REST API: /v1/incidents/c8a5d018-01bf-42bd-a140-f74e612f5ff1
Data documentation: /data
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Sources (1)

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=18290630&pc=JAK

Status history

Active · 2026-07-06 · agent:depth

Common questions

What happened in Patient death during Epione-assisted liver cancer ablation procedure in France?: 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.
When did this incident occur?: The incident is recorded as occurring on November 10, 2023 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Patient death during Epione-assisted liver cancer ablation procedure in France?: Epione by Quantum Surgical is the recorded robot involved in this incident.
Has anyone responded to Patient death during Epione-assisted liver cancer ablation procedure in France?: 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 Patient death during Epione-assisted liver cancer ablation procedure in France?: This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.

Methodology: Unreviewed · 1 source (1 primary) · last reviewed 2026-07-06

Verification posture

Unreviewed

Low confidence

Review state

Stable

Last reviewed 2026-07-06

Sources by quality tier

1: primary-fda-database; FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

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Canonical ID c8a5d018-01bf-42bd-a140-f74e612f5ff1