Recall
Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide…
Intuitive Surgical, Inc. · 23 Sept 2011
- Status
- Recall terminated
- Why, in the FDA's words
- “Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System.”
- Recall began
- 23 Sept 2011
- Company
- Intuitive Surgical, Inc.
- Device type
- Robot-assisted surgical systems (computer-controlled instruments) (NAY)
- Concerns
- K050005
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.