Open Letter Calling for the Immediate Resignation of Dave Rosa (CEO), Myriam Curet (CMO), and William Maisel (EVP & Senior Medical Officer), Due to Failure in Correcting a Known, Life-Threatening Defect in the da Vinci 5 Robotic Surgical Device

Dave Rosa(CEO, Left), Bill Maisel (VP, Middle), Myriam Curet (CMO, Right) of Intuitive surgical have been aware of, but failed to correct a life-threatening defect in the da Vinci 5 robotic surgery device

Dave Rosa, Myriam Curet, William Maisel,

You are well aware that the da Vinci Surgical System is the dominant robotic platform in U.S. operating rooms, used in tens of thousands of minimally invasive procedures annually across urology, gynecology, thoracic, general, and cardiac surgery. It is relied upon for its claimed advantages in precision, smaller incisions, reduced blood loss, and faster recovery — advantages that depend entirely on continuous, uninterrupted system performance during surgery.

When a surgeon is at the console, the patient is fully dependent on the system. There is no real-time manual fallback. Instruments are inside the patient, controlled remotely. Any sudden loss of visualization or control creates an immediate emergency that can lead to uncontrolled hemorrhage, organ or vessel injury, unintended instrument movement, emergent conversion to open surgery, prolonged anesthesia, or death.

Your December 2024 letter (MAT06450 v1 US 12/2024) states that routine hospital power fluctuations damage circuit boards, prevent booting, and cause prolonged intraoperative reboot delays requiring field-engineer replacement. The da Vinci 5 unified tower shares power across vision, E-200 generator, insufflator, and electronics with no isolation or intrinsic redundancy (FDA 510(k) K232610). Power interruption therefore risks simultaneous loss of visualization, control, and pneumoperitoneum maintenance.

Intuitive’s December 2024 customer notification letter (reference MAT06450 v1 US 12/2024)

Your only mitigation: extrinsic workarounds — daily unplug/replug, breaker cycling, external UPS. These are not device-level corrections. Most facilities lack proper UPS; most surgeons are unaware because the IFU omits this hazard.

Under 21 U.S.C. § 351(a)(2)(B), the device is adulterated: it fails CGMP design controls (21 CFR § 820.30). Under 21 U.S.C. § 352, it is misbranded: labeling omits known lethal risk and required safeguards.

These are criminal violations under the Food, Drug and Cosmetics Act (FDCA).

Persistent MAUDE reports confirm real intraoperative power failures. You have been directly informed — by surgeons, advocates, and data. Your own letter acknowledges this critical safety failure and defect. But, no intrinsic fix, no fleet grounding, no IFU update has followed.

Allowing the dominant robotic surgery platform to remain vulnerable to preventable power failure is the height of irresponsibility and negligence by Intuitive’s executive leadership. It directly undermines the core safety premise of the technology — continuous, reliable performance when instruments are inside the patient.

There is no remaining defense. Only continued exposure to danger and liability — for robotic surgery patients and Intuitive’s investors.

You have forfeited the credibility to lead a company whose flagship device can fail catastrophically mid-procedure due to a defect you documented but refuse to correct intrinsically.

The only responsible course is immediate resignation from your executive positions.

Step down.

Allow leadership that will prioritize patient safety over short-term financial considerations at Intuitive to take responsibility for the recall, intrinsic redesign, labeling correction, and full disclosure this situation requires.

To Intuitive Surgical’s board of directors and investors: the da Vinci 5 defect and vulnerability to power failures is not a trivial matter, it is clear and present danger to the safety of your customers and patients — and it is the result of executive leadership failure.

Hooman Noorchashm MD, PhD.