Robotic surgery was sold as the moment medicine finally caught up with science fiction, promising smaller incisions, fewer complications, and machine-level precision. Instead, a growing stack of lawsuits now paints a picture of operating rooms where artificial intelligence can misread anatomy, misdirect instruments, and leave patients with life-altering injuries. The core tension is no longer whether AI belongs in surgery, but whether the safeguards around it are remotely keeping pace with the risks.
At the center of the controversy are two flagship systems: Intuitive Surgical’s da Vinci platform and Medtronic’s TruDi Navigation System. Both were marketed as tools to extend a surgeon’s skill, not replace it, yet the litigation wave suggests a more troubling dynamic, where software glitches and overconfidence in automation may be combining into a new category of harm that traditional malpractice law was never designed to handle.
From promise to plaintiff: how da Vinci became a legal test case
The da Vinci Surgical System arrived in hospitals as a symbol of cutting-edge care, with four robotic arms and 3D visualization meant to make delicate procedures safer. Instead, a long-running series of complaints has accused the Vinci platform of causing electrical burns, organ damage, and other complications that patients say were never fully disclosed. According to detailed summaries of Vinci Robotic Surgery, plaintiffs argue that system malfunctions and design flaws turned routine operations into emergencies, while the manufacturer allegedly downplayed the risks.
One of the most vivid examples is the case of Sandra Sultzer, who underwent a robotic procedure in September 2021 and later developed severe abdominal pain and fever. Her lawsuit alleges that a robotic device burned her small intestine, forcing additional surgeries and a long recovery that she says could have been avoided if the technology had been safer and the warnings clearer. The filing against Intuitive Surgical, which makes da Vinci, describes a pattern of injuries and reports of patient harm that, according to Sandra Sultzer, should have triggered stronger action long before her operation.
Allegations and complaints: what patients say went wrong
Behind the legal filings is a consistent narrative: patients consented to minimally invasive surgery, not to being early adopters of complex robotics that may not have been fully vetted in real-world conditions. Allegations and Complaints collected by trial lawyers describe da Vinci procedures that ended with perforated organs, uncontrolled bleeding, and burns from stray electrical energy, all tied to the Vinci system’s instruments and energy delivery. Critics argue that Intuitive Surgical aggressively marketed the Vinci platform to hospitals and surgeons while underestimating the learning curve and the need for robust training and monitoring, a concern echoed in analyses that examine how Despite the popularity of the Vinci robot, complaints have steadily accumulated.
Legally, these cases are testing where responsibility lies when a high-tech tool is involved in harm: with the surgeon at the console, the hospital that bought the system, or the manufacturer that designed and promoted it. As of July, summaries of the Status of da Vinci Robotic Surgery Lawsuits note that there have been no global settlements and that litigation over the Vinci Surgical System remains active, with at least one new case filed in 2024. That slow grind through the courts suggests manufacturers are not eager to concede design defects or systemic problems, even as plaintiffs argue that the pattern of injuries points to more than isolated human error, a tension captured in updated overviews of the Vinci Surgical System litigation.
TruDi and the age of “hallucinating” surgical AI
If da Vinci raised alarms about mechanical and electrical risks, the TruDi Navigation System has pushed the debate into the era of algorithmic failure. TruDi is designed to guide surgeons through complex sinus and skull base procedures, using imaging and AI to map out safe paths around critical structures like the carotid arteries. According to recent complaints, however, TruDi’s AI features have been accused of “hallucinating” anatomy, misidentifying body parts, and pushing surgeons toward dangerous trajectories, a charge laid out in lawsuits that describe the system as a Navigation System that sometimes cannot be trusted.
The most striking early cases come from Two Texas patients who say TruDi’s AI misled their surgeons near the carotid arteries, allegedly contributing to blood clots and strokes. Their lawsuits claim the software’s guidance was treated as authoritative in the heat of surgery, even when it should have been questioned, and that Medtronic failed to adequately warn about the possibility of AI misidentification or to provide clear protocols for overriding the system. Those allegations, detailed in accounts of Two Texas lawsuits, crystallize a new kind of risk: not just a broken tool, but a persuasive digital assistant that can quietly steer human judgment off course.
Regulators race to catch up with 100 malfunctions and counting
Regulatory filings suggest these are not isolated anecdotes. Since AI was added to TruDi, the FDA has received unconfirmed reports of at least 100 m malfunctions and adverse events, a figure that includes software glitches, navigation errors, and unexpected behavior in the operating room. At least 10 injuries followed between late 2021 and November 2025, including cerebrospinal fluid leaks, skull punctures, and strokes from alleged instrument mislocation, according to detailed tallies of At least 10 serious cases. Regulators have stressed that these reports are unverified and that causation has not been formally established, but the volume alone is forcing a rethink of how AI-enabled devices are monitored once they leave the lab.
For now, the FDA’s primary tools remain adverse event databases, post-market surveillance requirements, and the threat of recalls or warning letters if patterns of harm become undeniable. Yet the TruDi experience shows how slowly those mechanisms can move compared with the pace of software updates and hospital deployments. Reports that misidentified body parts and botched surgeries have risen since AI integration, as described in analyses of how Since AI was added to the device, suggest that regulators are essentially chasing a moving target, trying to reconstruct what went wrong from sparse incident reports long after the fact.
Over‑reliance, hidden software fixes, and what comes next
Stepping back, the lawsuits against da Vinci and TruDi point to a deeper systems problem: AI tools are being dropped into high-stakes environments without a corresponding upgrade in training, oversight, or transparency. Surgeons are encouraged to trust navigation overlays and robotic assistance, yet they often have limited visibility into how an algorithm reached its recommendation or how it might fail. This dynamic invites over-reliance, especially in complex procedures where the human operator is already juggling anatomy, instruments, and time pressure. It is not hard to imagine a scenario where a surgeon hesitates to override the machine, worried that deviating from the AI’s path could later be second-guessed in court.
Looking ahead, I expect two shifts if these trends continue. First, regulators are likely to demand far more granular post-market data, including mandatory disclosure of software patches that address safety issues and clearer labeling when AI guidance is experimental or unvalidated for certain anatomies. Second, hospitals and insurers will probably push for new consent language and training standards that spell out the role of AI in each procedure, much as they did when laparoscopic surgery first spread. The comparison that keeps surfacing is the auto industry’s evolution from basic seatbelts to complex airbag and sensor systems: once injuries and recalls mounted, regulators forced manufacturers to prove not just that new features worked in ideal tests, but that they failed safely in the real world. Unless AI surgery tools can meet a similar bar, the wave of lawsuits that began with the Vinci platform and the TruDi Navigation System may be only the first swell of a much larger storm.
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*This article was researched with the help of AI, with human editors creating the final content.
