Recall
da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Intuitive Surgical, Inc. · 12 June 2023
- Status
- Recall open, classified
- Why, in the FDA's words
- “Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.”
- Recall began
- 12 June 2023
- Company
- Intuitive Surgical, Inc.
- Device type
- Robot-assisted surgical systems (computer-controlled instruments) (NAY)
- Concerns
- K131861
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.