Open Letter to Intuitive Surgical’ Executive Leadership: Your Stealth January 2026 “Clarification” Announcement Conceals a Serious da Vinci Power Failure Defect

Intuitive Surgical’s executives - CEO, Dave Rosa (Top Left), General Counsel, Gary Loeb (Top Right), Vice President and Senior Medical Officer, Bill Maisel (Bottom Left), and CMO, Myriam Curet (Bottom Right) - are responsible for publishing a January 2026 Clarification Announcement from Intuitive Surgical.

Mr. Rosa, Dr. Curet, Dr. Maisel and Mr. Loeb,

I write with serious concern regarding the inappropriate January 2026 public statement issued by Intuitive Surgical, under your leadership, entitled “Clarification Regarding December 2024 Customer Communication”:

https://www.intuitive.com/en-us/about-us/newsroom/Clarification-Regarding-December-2024-Customer-Communication

While I understand the company’s desire to address public discussion of the December 2024 customer notification (MAT06450 v1 US 12/2024), the framing adopted in the January 2026 statement appears to materially understate and obfuscate the nature and severity of the issue described in your own earlier communication. Frankly, your clarification announcement is transparent in its aim to conceal both a severe da Vinci defect, and Intuitive executives’ foundational regulatory failure in committing an adulteration and misbranding violation.

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

The December 2024 letter explicitly states that foreseeable and routine facility power fluctuations — events known to occur during normal hospital operations — can result in 1) repeated power interruptions, 2) damage to critical circuit boards, 3) failure of the system to boot, and 4) necessity of field service engineer intervention and component replacement.

These consequences describe a foreseeable hazardous situation under established risk-management standards (ISO 14971:2019). In the context of the da Vinci 5 unified tower architecture, such an interruption simultaneously compromises 3D visualization, active insufflation, and powered instrument functionality during an ongoing procedure — functions essential to safe continuation of surgery.

Your January 2026 statement characterizes the December 2024 communication as a routine “power outage preparedness” advisory and asserts that no new hazards have been identified. This characterization is false and stands in direct tension with several objective facts:

1. The vulnerability is intrinsic to the device design rather than dependent solely on external environmental factors or user practices.
2. The proposed risk controls — daily power cycling, circuit breaker manipulation, and hospital-procured external uninterruptible power supplies — are extrinsic measures that occupy the lowest tier of the risk-control hierarchy.
3. No design-level corrective action has been publicly described or implemented to address the single-point failure mode inherent in the unified tower architecture.
4. The Instructions for Use do NOT contain explicit, prominent warnings concerning the foreseeable risk of complete intraoperative system failure secondary to routine facility power events — contrary to your statements in the January 2026 announcement.

On the last point, Intuitive’s January 2026 statement claims that the December 2024 communication is “aligned” with the Instructions for Use (IFU). This assertion is False. A careful review of the currently available da Vinci 5 IFU reveals that the Warnings and Cautions sections contain no mention of vulnerability to facility power loss, power fluctuations, power interruptions, or the risk of complete intraoperative system blackout. There is no caution or warning directing users to anticipate or prepare for the specific hazardous outcomes explicitly described in the December 2024 letter — namely, repeated interruptions, circuit-board damage, boot failure, or the need for field service replacement of components following routine power events. The absence of any such language in the IFU directly contradicts the claim of alignment and further underscores the need for updated labeling to reflect the documented risk.

Continued reliance on extrinsic controls, absent corresponding updates to labeling and design, raises questions of compliance with 21 CFR Part 801 (labeling requirements) and, potentially, the misbranding and adulteration provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 351, 352).

Multiple entries in the FDA MAUDE database already document intraoperative power-loss events involving da Vinci 5 (and prior iteration of da Vinci), including sudden loss of visualization and insufflation, emergency conversions to open or laparoscopic surgery, and activation of facility backup generators. These reports indicate that the hazard is not merely theoretical.

In light of the above, I respectfully request that Intuitive Surgical give serious consideration to the following actions within the next 10 business days:

1. Withdraw or substantially revise the January 2026 clarification statement to accurately reflect the intrinsic nature of the power-related vulnerability described in the December 2024 customer letter.
2. Issue an urgent safety notice to all da Vinci users describing the risk of complete intraoperative power loss from foreseeable facility power fluctuations in all you da Vinci robotic systems.
3. Amend the Instructions for Use to include clear and prominent warnings regarding this specific hazard and its potential clinical consequences.
4. Provide the FDA with a detailed corrective-action plan that includes evaluation of design-level mitigations for the unified tower single-point failure mode.
5. Step down from the company’s leadership and provide your board of directors and investors with an opportunity to select a more competent leadership.
6. Report the da Vinci power defect to investors via an SEC filing
7. Instruct all user facilities to cease use of da Vinci robotic systems until such time as Intuitive can ensure that every unit in the marketplace is immune to ambient power fluctuations.

My intent in raising these concerns remains unchanged as a public health advocate and academic legal researcher: to protect surgical patients from preventable serious adverse events. I believe that your intent should be the same. Therefore, prompt, transparent, and design-focused remediation is both medically necessary and in the long-term interest of Intuitive Surgical, its users, its investors, and the public.

https://law.northeastern.edu/ajrc-petitions-fda-for-recall-of-da-vinci-surgical-systems/

Your January 2026 clarification published by Intuitive Surgical’s Newsroom has compounded the problem your firm faces, by publicly minimizing a documented intrinsic da Vinci vulnerability in a manner that may delay aggressive necessary corrective action, prolong patient exposure to the potentially deadly hazard, and increases your company’s exposure to scrutiny and liability.

I am available should you or your board of directors wish to discuss these matters in greater detail. Our goals should be aligned: Patient safety and strict regulatory compliance.

Sincerely,

Hooman Noorchashm MD, PhD.