Three months after the FDA cleared Intuitive Surgical's da Vinci SP for mastectomy, an Oakland hospital became what Sutter Health calls "among the first" in the country to use the new indication outside a clinical trial — enabled by a $2 million philanthropic gift, not a capital budget.

On December 15, 2025, the FDA issued 510(k) clearance K252675 authorizing Intuitive Surgical's da Vinci SP single-port robotic system for nipple-sparing mastectomy — an indication the device had lacked for the seven years since its original 2018 clearance. Less than three months later, on March 9, Dr. Rita Kwan-Feinberg of Sutter East Bay Medical Group used the system at Oakland's Alta Bates Summit Medical Center to perform what Sutter Health describes as among the first such procedures at a U.S. community-based hospital outside a clinical trial.

The patient was Vicky Pan, a 45-year-old Moraga resident who had been diagnosed with Stage 3 triple-negative breast cancer — the most aggressive type — that had spread to her lymph nodes. She had spent six months in chemotherapy and immunotherapy before facing the surgery decision. The robotic approach, backed by clinical-trial data showing fewer complications, less scarring, and higher rates of preserved nipple sensation, was the alternative to a traditional mastectomy. Pan knew she was going first. "The con, of course, is I was the first person," she told the SF Chronicle. "There are risks involved there. But I weighed my options. I didn't think it was that big of a risk compared to the pros."

The machine at Alta Bates — nicknamed "Carol" — came to the hospital not through a capital equipment line but through a $2 million philanthropic gift from Peter Read, who named it after his late wife, Carol Ann Read. "Helping Dr. Kwan-Feinberg and the entire team bring this remarkable equipment to Sutter Health — and ensuring our community is the first in the region to benefit from these advanced treatments — has been an incredibly meaningful journey," Read said in the Sutter Health press release. The da Vinci SP is a mature commercial product from Sunnyvale-based Intuitive Surgical (NASDAQ: ISRG); the December 2025 mastectomy clearance is an indication expansion onto existing installed hardware, not a new device launch. Kwan-Feinberg described the stakes of preserving sensation: "Being able to preserve one's skin sensation and nipple sensation is a really huge advantage for the patient and the woman because this is often tied to a sense of self and sexual health," she told the Chronicle.

Several things remain unresolved. Sutter's own press release frames the achievement as "among the first in the U.S." rather than a clean superlative — the precise ranking across all centers holding a da Vinci SP has not been independently confirmed. Intuitive Surgical does not publicly break down its installed-base utilization by indication, so how many U.S. systems have since been used for nipple-sparing mastectomy is unknown. No complication or case-volume data from Alta Bates's initial procedures has been published. The pace at which this moves from an Oakland donor-funded first to a routine community-hospital option will depend on both access to the $2 million hardware and the supply of surgeons trained for the specific approach — neither of which Sutter's announcement addresses.