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Incident · Regulatory action

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.

Occurred 2013-07-19 · da Vinci (and Ion)

Machine-readable surfaces

Sources (2)

  1. AboutLawsuits · https://www.aboutlawsuits.com/intuitve-surgical-warning-da-vinci-problems-51257/
  2. The Clark Firm · https://www.theclarkfirmtexas.com/fda-warning-letter-for-intuitive-surgical-robot-manufacturer/

Common questions

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) is the recorded robot involved in this incident.
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.
Methodology: Verified · 2 sources (no primary) · last reviewed 2026-06-04

Verification posture

Verified

Low confidence

Review state

Stable

Last reviewed 2026-06-04

Sources by quality tier

2
unclassified
Unclassified source

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

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

Canonical ID bb9555eb-07c7-43b9-bda2-08b08c7f0352