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FDA warning letter to Intuitive Surgical over late reporting of da Vinci corrections and adverse events

[REGULATORY ACTION]

Jul 19, 2013 · Intuitive Surgical · da Vinci (and Ion) · South Korea

All Incidents

Failure Mode

REGULATORY ACTION

Event Date

Jul 19, 2013

Primary Entity

Intuitive Surgical

Robotic Platform

da Vinci (and Ion)

Jurisdiction / Location

South Korea

Audit Standard

Physical State Verified

Incident Abstract & Audit Findings

After Apr-May 2013 inspections, the FDA issued Intuitive a warning letter (Jul 19 2013) citing it for warning customers about a device correction (Hot Shears) without properly notifying the agency and for MDR-reporting deficiencies. A reporting-compliance regulatory action (distinct from the May 2013 Hot Shears device recall); later closed out. Cap-flag: dated facts corroborated via legal-news sources; the primary FDA letter was not directly retrieved.

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.aboutlawsuits.com/intuitve-surgical-warning-da-vinci-problems-51257/

    https://www.aboutlawsuits.com/intuitve-surgical-warning-da-vinci-problems-51257/

  • https://www.theclarkfirmtexas.com/fda-warning-letter-for-intuitive-surgical-robot-manufacturer/

    https://www.theclarkfirmtexas.com/fda-warning-letter-for-intuitive-surgical-robot-manufacturer/

  • https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters

    https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters

Related Incidents & Failure Precedents

6 records on file

Incident Context & FAQ

What happened in FDA warning letter to Intuitive Surgical over late reporting of da Vinci corrections and adverse events?

After Apr-May 2013 inspections, the FDA issued Intuitive a warning letter (Jul 19 2013) citing it for warning customers about a device correction (Hot Shears) without properly notifying the agency and for MDR-reporting deficiencies. A reporting-compliance regulatory action (distinct from the May 2013 Hot Shears device recall); later closed out. Cap-flag: dated facts corroborated via legal-news sources; the primary FDA letter was not directly retrieved.

When did this incident occur?

The incident is recorded as occurring on July 19, 2013 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.

What robot was involved in FDA warning letter to Intuitive Surgical over late reporting of da Vinci corrections and adverse events?

da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.

Has anyone responded to FDA warning letter to Intuitive Surgical over late reporting of da Vinci corrections and adverse events?

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 FDA warning letter to Intuitive Surgical over late reporting of da Vinci corrections and adverse events?

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