# FDA 483 - Intuitive Surgical, Inc. - December 14, 2023

Source: https://www.keypedia.com/records/483/intuitive-surgical-inc/5ebe9d89-9bfc-4a76-a3ab-929c8f1101c5

> FDA 483 for Intuitive Surgical, Inc. on December 14, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intuitive Surgical, Inc.
- Inspection Date: 2023-12-14
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Intuitive Surgical, Inc. in Sunnyvale, CA, a medical device manufacturer, revealed a significant quality system deficiency related to its corrective and preventive action (CAPA) procedures. Specifically, the company failed to adequately investigate and establish root causes for a recall involving a loose Universal Surgical Manipulator (USM) carriage, indicating a breakdown in their CAPA process. This issue suggests a need for improved design control and investigational practices to prevent recurrence.

## Related Documents

- [WARNING_LETTER - 2013-05-30](https://www.keypedia.com/records/warning_letter/intuitive-surgical-inc/cfd95f15-db91-4600-a204-7d66594ec298)
- [483 - 2013-05-30](https://www.keypedia.com/records/483/intuitive-surgical-inc/b4234888-7638-4b8a-9121-7fa77e8e621e)
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- [483 - 2021-08-27](https://www.keypedia.com/records/483/intuitive-surgical-inc/983c7973-fe89-4610-8845-0f8a99212d37)
- [483 - 2025-11-05](https://www.keypedia.com/records/483/intuitive-surgical-inc/be41201e-33fd-4a82-8e0f-87625b3e33bc)

## Related Officers

- [investigator](https://www.keypedia.com/people/elizabeth-a-dakan/f701338d-0484-431b-8bd5-9db442b5f079)
- [investigator](https://www.keypedia.com/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b