Intuitive Surgical Recalls EndoWrist One Vessel Sealer for Labeling and Software Issues
Intuitive Surgical is voluntarily correcting labeling and software for the EndoWrist One Vessel Sealer used with the da Vinci Si Surgical System.
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 a voluntary correction for labeling and software issues without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Intuitive Surgical, Inc. is initiating a voluntary correction for the EndoWrist One Vessel Sealer, a bipolar electrosurgical instrument used with the da Vinci Si Surgical System (IS3000) and the ERBE VIO 300 D electrosurgical generator. The recall involves 1,483 devices distributed worldwide, including the United States, Australia, and various European and Asian countries.
The correction addresses issues related to the labeling and software associated with the device. The EndoWrist One Vessel Sealer is intended for grasping and blunt dissection of tissue, as well as for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter.
Healthcare providers and facilities using the affected devices should contact Intuitive Surgical for instructions on the voluntary correction. The specific part numbers involved are PN 410322-04 and PN 410322-05.
The recalled product
- Product
- EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended…
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 1,483
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part Number: PN 410322-04
Distribution
Distributed nationwide across the United States.
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