Intuitive Surgical, Inc. is recalling 53 units of the Patient Cart (Part 380601), which is a key component of the da Vinci SP Surgical System (Model SP1098). The recall was initiated because certain joints in the surgical instrument arms may have inadequately welded belts. If these belts fail, it could result in internal tissue injuries to the patient, body wall injuries, or the need to suddenly switch to a traditional open surgery. In some cases, the defect could also cause a pinching injury to the surgical staff, though no patient harm has been reported from that specific type of failure. Patients and providers should contact the manufacturer regarding the affected serial numbers, which include SP0202 through SP0282.
The inadequately welded belts in the instrument arm joints can break during surgery, leading to unintended movement of the surgical tools inside the patient or mechanical failure that forces an emergency conversion to open surgery. This poses a risk of internal organ damage, tissue injury, or physical injury to the medical staff operating the system.
Manufacturer notification and potential repair/inspection.
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 ยท Raw API Response
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