# FDA 483 - Intuitive Surgical, Inc. - March 06, 2020

Source: https://www.globalkeysolutions.net/records/483/intuitive-surgical-inc/83171c7b-3c5e-4b20-9e59-25937b39127b

> FDA 483 for Intuitive Surgical, Inc. on March 06, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intuitive Surgical, Inc.
- Inspection Date: 2020-03-06
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Intuitive Surgical, Inc. in Sunnyvale, CA, a medical device manufacturer, revealed significant deficiencies across multiple areas. The firm failed to adequately maintain complaint files, particularly regarding investigations into patient deaths and device retrieval, and did not clearly identify MDR-reportable events. Additionally, issues were noted with contamination control procedures in a cleanroom environment and with the timely and complete submission of Medical Device Reports (MDRs).

## Related Documents

- [WARNING_LETTER - 2013-05-30](https://www.globalkeysolutions.net/records/warning_letter/intuitive-surgical-inc/cfd95f15-db91-4600-a204-7d66594ec298)
- [483 - 2013-05-30](https://www.globalkeysolutions.net/records/483/intuitive-surgical-inc/b4234888-7638-4b8a-9121-7fa77e8e621e)
- [483 - 2021-08-27](https://www.globalkeysolutions.net/records/483/intuitive-surgical-inc/983c7973-fe89-4610-8845-0f8a99212d37)
- [483 - 2023-12-14](https://www.globalkeysolutions.net/records/483/intuitive-surgical-inc/5ebe9d89-9bfc-4a76-a3ab-929c8f1101c5)
- [483 - 2025-11-05](https://www.globalkeysolutions.net/records/483/intuitive-surgical-inc/be41201e-33fd-4a82-8e0f-87625b3e33bc)

## Related Officers

- [Amogh Pathi](https://www.globalkeysolutions.net/people/amogh-pathi/1325ce17-ca08-4cfb-818e-37889eccb31b)
- [investigator](https://www.globalkeysolutions.net/people/eric-j-heinze/f16828ab-f1e0-4556-bccc-700d93965b86)
- [Investigator](https://www.globalkeysolutions.net/people/james-a-lane/f6cd3d8d-7de9-45c5-9380-7e0c5de4720e)

Company: https://www.globalkeysolutions.net/companies/intuitive-surgical-inc/2dea1052-5e1b-4f51-b3e3-6792452d36de

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822