Intuitive Surgical, Inc. is recalling approximately 2,781 da Vinci X and da Vinci Xi Surgical Systems. These systems utilize robotic arms (Universal Surgical Manipulators) that contain internal screws susceptible to breaking during use. If a screw breaks, it could lead to mechanical failure of the surgical arm during an operation. The recall affects systems worldwide, including across nearly every U.S. state, that were manufactured in the United States.
Broken screws within the arm sub-assembly can cause the robotic manipulator to malfunction or lose structural integrity while a procedure is underway. This defect poses a risk of surgical delay or unintended movement of the instruments inside the patient, potentially causing internal injury.
Affected component is the USM (Universal Surgical Manipulator) arm sub-assembly part 380647-xx. FDA Medical Device Listing Numbers: D531324 and D295931.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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