Recall
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi English SRK.. General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories…
Intuitive Surgical, Inc. · 15 March 2017
- Status
- Recall terminated
- Why, in the FDA's words
- “Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.”
- Recall began
- 15 March 2017
- Company
- Intuitive Surgical, Inc.
- Device type
- Robot-assisted surgical systems (computer-controlled instruments) (NAY)
- Concerns
- K140553
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.