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Patient death linked to da Vinci SureForm 30 Gray stapler reload producing incomplete staple line on blood vessel

[FATALITY]

Dec 20, 2025 · Intuitive Surgical · da Vinci (and Ion) · Hong Kong, China

All Incidents

Failure Mode

FATALITY

Event Date

Dec 20, 2025

Primary Entity

Intuitive Surgical

Robotic Platform

da Vinci (and Ion)

Jurisdiction / Location

Hong Kong, China

Audit Standard

Physical State Verified

Incident Abstract & Audit Findings

Intuitive Surgical reported one patient death and four serious injuries associated with incomplete staple line formation from 8mm SureForm 30 Gray Reloads used with the da Vinci Surgical System. The da Vinci robot returned a completed stapler fire, but the staple line was incomplete, causing the cut blood vessel to bleed and requiring conversion to open surgery.

System & Fleet Architecture

Operating Manufacturer

Intuitive SurgicalView Manufacturer

Hardware Platform

da Vinci (and Ion)

Operational Sectors

Physical AI / Robotics

Primary Sources & Evidentiary Filings

  • https://www.fiercebiotech.com/medtech/intuitive-recalls-surgical-stapler-reloads-following-patient-death

    https://www.fiercebiotech.com/medtech/intuitive-recalls-surgical-stapler-reloads-following-patient-death

  • https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/surgical-stapler-reload-recall-intuitive-surgical-removes-8mm-sureform-30-gray-reloads

    https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/surgical-stapler-reload-recall-intuitive-surgical-removes-8mm-sureform-30-gray-reloads

Related Incidents & Failure Precedents

6 records on file

Incident Context & FAQ

What happened in Patient death linked to da Vinci SureForm 30 Gray stapler reload producing incomplete staple line on blood vessel?

Intuitive Surgical reported one patient death and four serious injuries associated with incomplete staple line formation from 8mm SureForm 30 Gray Reloads used with the da Vinci Surgical System. The da Vinci robot returned a completed stapler fire, but the staple line was incomplete, causing the cut blood vessel to bleed and requiring conversion to open surgery. Intuitive learned of the death in late December 2025 and issued a recall recommendation on March 11, 2026; the FDA classified it as a Class I recall on May 5, 2026.

When did this incident occur?

The incident is recorded as occurring on December 20, 2025 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 linked to da Vinci SureForm 30 Gray stapler reload producing incomplete staple line on blood vessel?

da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at Hong Kong, China.

Has anyone responded to Patient death linked to da Vinci SureForm 30 Gray stapler reload producing incomplete staple line on blood vessel?

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 linked to da Vinci SureForm 30 Gray stapler reload producing incomplete staple line on blood vessel?

This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.