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Recall

Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003

Intuitive Surgical, Inc. · 1 July 2022

Status
Recall open, classified
Why, in the FDA's words
“Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.”
Recall began
1 July 2022
Company
Intuitive Surgical, Inc.
Device type
Robot-assisted surgical systems (computer-controlled instruments) (NAY)
Concerns
K050369

What it means

A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.

The record

The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.
FDA database