DEPLOYDatabase

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 · Surgical robots · Investigated by FDA

How to read this record

Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
Track Patient death during Epione-assisted liver cancer ablation procedure in France

Machine-readable surfaces

Sources (1)

  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: Verified · 1 source (1 primary) · last reviewed 2026-07-22

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-07-22

Sources by quality tier

1
primary-fda-database
FDA database

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

Methodology surface for Patient death during Epione-assisted liver cancer ablation procedure in France.

Deploy Watch

Track this incident.

We notify you when the regulator updates the record, the remedy status changes, or a related incident surfaces.

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