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

[FATALITY]

Nov 10, 2023 · Quantum Surgical · Epione · Leeds, UK

All Incidents

Failure Mode

FATALITY

Event Date

Nov 10, 2023

Primary Entity

Quantum Surgical

Robotic Platform

Epione

Jurisdiction / Location

Leeds, UK

Audit Standard

Physical State Verified

Incident Abstract & Audit Findings

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.

System & Fleet Architecture

Operating Manufacturer

Quantum SurgicalView Manufacturer

Hardware Platform

EpioneView Spec

Operational Sectors

Physical AI / Robotics

Primary Sources & Evidentiary Filings

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

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

Related Incidents & Failure Precedents

6 records on file

Incident Context & FAQ

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 at Leeds, UK.

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.