Recall
VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
Intuitive Surgical, Inc. · 3 March 2022
- Status
- Recall completed
- Why, in the FDA's words
- “Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.”
- Recall began
- 3 March 2022
- Company
- Intuitive Surgical, Inc.
- Device type
- Robot-assisted surgical systems (computer-controlled instruments) (NAY)
- Concerns
- K173337
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.