PV Bulletin

Urgent Safety Notification - da Vinci X and Xi Instruments - Intuitive Surgical

ANSM warns of defective grip cables in da Vinci X and Xi surgical instruments causing potential patient risks.

Primary source: Téléchargez le courrier de la société Intuitive Surgical Inc de janvier 2025 (13/01/2025)

Translated From French

PV Bulletin does not take any responsibility for translation errors or omissions, though it has used the best available translation engine.

PV Impact Brief

Urgency: HighConfidence: high

What changed

The ANSM registered this safety action under R2434728 following a rise in complaints about frayed or broken grip cables on da Vinci surgical instruments.

Why it matters

This safety issue affects critical surgical instruments used during operations, potentially impacting patient safety and outcomes. Immediate awareness and compliance with reporting requirements are necessary to mitigate risks.

Action needed

Healthcare providers using da Vinci X and Xi instruments must report any incidents associated with cable degradation and follow updated guidelines for the safe use of these instruments.

Relevant for
QPPVMedical Safety Lead
Processes impacted
Signal Management
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Sep 7, 2026

Full briefing

Practical implication

Healthcare providers using da Vinci X and Xi instruments must report any incidents associated with cable degradation and follow updated guidelines for the safe use of these instruments.

The ANSM has issued an urgent safety notification regarding defective grip cables in reusable da Vinci X and Xi surgical instruments. This issue, arising from an increasing number of complaints, poses a risk of loss of functionality and potential introduction of tungsten cable particles into the patient's body during procedures. Corrective actions and reporting measures have been implemented by Intuitive Surgical to address these risks.

What changed: The ANSM registered this safety action under R2434728 following a rise in complaints about frayed or broken grip cables on da Vinci surgical instruments.

Why it matters: This safety issue affects critical surgical instruments used during operations, potentially impacting patient safety and outcomes. Immediate awareness and compliance with reporting requirements are necessary to mitigate risks.

Practical implication: Healthcare providers using da Vinci X and Xi instruments must report any incidents associated with cable degradation and follow updated guidelines for the safe use of these instruments.

View original source

  • Source: ANSM (France) - Safety information feed
  • Published at source: 2026-09-07T00:00:00.000Z
  • Discovered by monitor: 2026-09-07T21:36:51.045Z

Published from the regulator source ingestion pipeline after PV impact triage.

#Safety Signal#Safety Signals#Source-ingestion#Regulator-monitor#Translated From French#France#Ansm.sante.fr

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