Intuitive Surgical, Inc. is recalling 8,247 reusable surgical instruments, specifically the Tenaculum Forceps and Permanent Cautery Hook used with da Vinci S and Si surgical systems. The recall was initiated due to an increase in reports of pitch cables inside the instruments fraying or breaking during use. If a cable breaks during a procedure, the instrument tip may stop moving or respond incorrectly to the surgeon's commands, potentially requiring the surgery to be paused or converted to a different method.
Frayed or broken cables can cause the surgical instrument to malfunction or lose its range of motion while inside a patient's body. This failure can lead to unintended tissue damage, longer surgery times, or the need for more invasive surgical techniques to complete the procedure safely.
System numbers represent specific da Vinci systems where instruments were used or associated.
System numbers represent specific da Vinci systems where instruments were used or associated.
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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