Intuitive Surgical Recalls EndoWrist Vessel Sealers Due to Grip Interference
Intuitive Surgical is recalling EndoWrist One Vessel Sealers because manufacturing variability may cause interference in the instrument grips.
What this means for you
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 the source text describes a mechanical defect (interference) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Intuitive Surgical, Inc. is recalling the EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack. This bipolar electrosurgical instrument is used with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator for grasping tissue and coagulating vessels.
The recall is due to a potential for interference in the back of the instrument grips. This issue is attributed to manufacturing variability in some of the instrument jaws. The recall covers 3,282 units distributed nationwide in the United States and internationally to multiple countries including Australia, Belgium, China, and the United Kingdom.
Healthcare facilities and users should stop using the affected EndoWrist One Vessel Sealers and contact Intuitive Surgical for further instructions. The specific part number is 480322-04, and affected lot numbers are listed in the official recall documentation.
The recalled product
- Product
- EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator. It
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 3,282
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)
- PN 480322-04
Distribution
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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