# fda_warning_letter (us_fda)

FDA Warning Letter to Intuitive Surgical (2013) over late / inadequate reporting of da Vinci device corrections and adverse events.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_warning_letter
- Status: closed
- Filing date: 2013-07-16
- Verification posture: verified
- Cap-flag notes: Issuance date 2013-07-16 per press citing the FDA letter (original 2013 letter de-listed from the live FDA database).

## Applicant

- [Intuitive Surgical](/companies/intuitive-surgical.md)

## Covered models (1)

- [da Vinci (and Ion)](/models/intuitive-da-vinci.md)

## Related incident

_Recall-is-both seam: this filing is paired with its incident-layer companion when the filing is a recall._

- [FDA warning letter to Intuitive Surgical over late reporting of da Vinci corrections and adverse events](/incidents/intuitive-fda-warning-letter-2013.md)

## Sources (1)

- [https://www.fda.gov/medical-devices/warning-letters](https://www.fda.gov/medical-devices/warning-letters)

_Canonical URL: /regulatory-filings/fda-warning-letter-intuitive-2013. HTML version: [/regulatory-filings/fda-warning-letter-intuitive-2013](/regulatory-filings/fda-warning-letter-intuitive-2013)._