Intuitive Surgical da Vinci Single Site Instruments Recalled for Missing Manual Revisions
Intuitive Surgical is recalling specific da Vinci Single Site instruments because they were shipped without the correct user manual revision, which contains necessary instructions, warnings, and precautions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a documentation issue (missing manual revision) rather than a physical defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Intuitive Surgical, Inc. is recalling a limited number of FDA-cleared instruments for da Vinci Single Site use, specifically the Bipolar Maryland and curved needle Driver. The recall is due to a documentation error where these devices were shipped without the correct revision of the user manual. The missing manual revision provided added instructions for the use of these additional Single Site instruments, including specific indications, warnings, and precautions.
The affected products are the da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000). These instruments are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery, and suturing. The recall covers 504 devices for a total of 2,220 affected clinical products. The distribution was worldwide, including the United States (nationwide) and Australia, Belgium, France, Italy, and the United Kingdom.
The specific model number is 428088-12. The affected units were distributed between March 15, 2013, and July 19, 2013. The recall is classified as Class II by the FDA. Users should check their inventory for these specific model numbers and lot dates to ensure they are not using the affected instruments without the correct manual revision.
The recalled product
- Product
- Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment…
- Manufacturer
- Intuitive Surgical, Inc.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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