The Fight Over Intuitive Surgical’s Locked EndoWrist Market
A counter typically disables each da Vinci instrument after ten activations. When an independent repair service offered hospitals more uses at a lower price, Intuitive’s contracts and warnings shut that option down. A federal appeals court has now revived the resulting antitrust case.
Antitrust · Surgical roboticsTL;DR
- Surgical Instrument Service Company presented trial evidence that Intuitive Surgical controlled more than 99% of the U.S. market for minimally invasive soft-tissue surgical robots and 100% of the market for the instruments attached to them.
- Intuitive’s EndoWrist instruments contain counters that typically stop them from working after ten activations, regardless of how long or intensively they were used.
- SIS and Rebotix offered an inspection, refurbishment and counter-reset service priced 40% below a new EndoWrist. All six participating hospitals stopped using it after Intuitive warned of contract breaches and possible limits on robot service calls.
- Intuitive cited engineering and patient-safety concerns. Rebotix presented testing beyond 29 uses, and the six-month SIS program produced no evidence of patient harm, but the appeals court did not decide the safety dispute.
- The Ninth Circuit ruled that the trial judge imposed the wrong legal test and rejected Intuitive’s request to preserve its victory on evidentiary grounds.
- The court did not find Intuitive liable for an antitrust violation. It reversed the judgment and returned the case for further proceedings.
The appeal restores a jury’s ability to consider whether dominance in surgical robots was used to suppress competition over the tools hospitals must keep buying.
Every EndoWrist instrument attached to Intuitive Surgical’s da Vinci robot carries a built-in use counter. It’s usually loaded with ten “lives.” Each activation removes one, whether the instrument was used for an entire operation or briefly tested. At zero, the tool stops working.
Intuitive says that limit reflects engineering constraints and patient-safety considerations. Its own early business plan also described a commercial purpose: recurring revenue from high-margin instruments that could be sterilized and reused only as many times as the company permitted.
That system became the center of an antitrust case after an independent repair company found a way to extend the instruments’ working lives. The service operated at roughly six hospitals for about six months in 2019. Then Intuitive sent warning letters. Every hospital stopped using it.
The Facts
The da Vinci is a robot-assisted system for minimally invasive soft-tissue surgery. A surgeon sits at a console and controls robotic arms beside the operating table. EndoWrist instruments attached to those arms translate the surgeon’s hand movements inside the patient through small incisions.
The system combined features of open surgery with smaller incisions associated with laparoscopic procedures. The opinion recounts evidence of reduced bleeding, pain, scarring, hospital stays and recovery times compared with open or conventional laparoscopic surgery. It also notes that some cancer procedures performed with the da Vinci can’t be performed laparoscopically.
That clinical role helped make the robot difficult for hospitals to avoid. The trial record described surgeons being trained on the da Vinci in medical school and hospitals needing the system to recruit them. Intuitive had installed more than 5,000 robots in the United States, compared with only a few dozen machines from competitors.
A Recurring-Revenue Machine Built Into the Tool
An EndoWrist’s programmed life isn’t based on the duration or intensity of each activation. Once the counter reaches zero, the instrument becomes unusable unless its electronics are modified.
Intuitive’s sales agreement prohibits customers from using the da Vinci with an instrument that Intuitive didn’t make or approve. A separate license and service agreement says the limited license for an EndoWrist expires at its maximum number of uses and prohibits unapproved repair, refurbishment or reconditioning.
The resulting commercial chain is straightforward: hospitals acquire the dominant robot, the robot accepts only instruments made or approved by its manufacturer, and each instrument expires on a schedule programmed by that same manufacturer.
How the purchasing loop works
What the documents said
“a business model based on recurring revenue rather than revenue from sale of capital equipment”Intuitive founding business-plan document quoted in the opinion
“high margin ‘resposable’ instruments which can be resterilized and reused only for the number of times allowed by the company”Business-plan language quoted in the opinion
The Repair Option That Lasted Six Months
Surgical Instrument Service Company, or SIS, is a family-run business that repairs and refurbishes surgical tools for hospitals and surgery centers. In spring 2019, it learned that another company, Rebotix, could modify an EndoWrist circuit board and reset its counter.
The companies divided the work. SIS marketed the service through its hospital relationships, inspected and refurbished the instruments, and handled cleaning. Rebotix reset the counters. SIS charged 40% less than the price of a new EndoWrist from Intuitive.
Beginning in June 2019, around six hospitals used the service for approximately six months. According to the record described by the court, the refreshed instruments performed as expected and there was no evidence of patient harm during that period.
Intuitive then sent letters “strongly discourag[ing]” the hospitals from using the service. The company said using an EndoWrist past its programmed limit materially breached its agreements and warned that it might stop accepting service calls for da Vinci systems used with instruments refurbished by an unauthorized third party.
Every participating hospital dropped SIS’s EndoWrist service. The direct consequence established by the record is narrow but concrete: six hospitals lost access to that lower-priced repair option, and SIS lost those customers. The opinion doesn’t quantify what hospitals subsequently spent on replacements or connect the restriction to patient bills, insurance costs or public healthcare spending.
The pressure described in the record
“Intuitive may no longer accept [the hospitals’] service calls for” the da Vinci.Warning language from Intuitive’s hospital letters, as quoted by the court
What the Record Does—and Doesn’t—Establish About Safety
Rebotix tested a representative sample of EndoWrists through 29 uses and reported no degradation in performance or condition. It tested a smaller sample past 50 uses and again reported no signs of material degradation. The opinion doesn’t state how many instruments were included in either sample.
Intuitive had performed safety validation only through each instrument’s programmed number of uses. It maintained that the counter reflected engineering limitations and patient-safety considerations. The company also pointed out that neither SIS nor Rebotix responded when it later requested clinical evidence of the service’s safety and effectiveness.
Those facts don’t produce a judicial answer about how many uses are safe. Rebotix’s tests and the absence of reported harm during a limited six-month program support SIS’s position, but they aren’t the same as a court finding that indefinite reuse is safe. Nor does Intuitive’s invocation of safety establish that every contractual restriction was competitively justified.
The Ninth Circuit explicitly declined to decide whether Intuitive’s controls served patients’ best interests or whether the trial court mishandled evidence involving the Food and Drug Administration. Neither party had properly placed those issues before the appeals court.
How a Jury Instruction Ended the First Trial
SIS sued in May 2021. It alleged tying, exclusive dealing, monopolization and attempted monopolization under the Sherman Act. In ordinary language, SIS claimed Intuitive used its control over the robot market to require hospitals to buy replacement instruments from Intuitive and block independent repair competition.
The case reached a three-week trial in January 2025. The decisive dispute concerned the test SIS had to satisfy before a jury could consider those claims.
The trial judge ultimately required SIS to prove four factors drawn from the Supreme Court’s Kodak case and the Ninth Circuit’s Epic Games decision. Those factors are used when a company faces competition in a primary market but allegedly gains power over customers after they buy its product. They examine whether customers knew about the later restrictions, could calculate lifetime costs, faced significant switching costs and formed a legally distinct aftermarket.
SIS had presented no evidence aimed at that test. Once the judge confirmed that the jury would receive the instruction, SIS stipulated to judgment for Intuitive and appealed.
Intuitive introduces the first da Vinci surgical robot.
SIS learns that Rebotix can reset EndoWrist use counters.
SIS begins offering the repair and reset service to hospitals.
All participating hospitals stop using SIS after receiving Intuitive’s warnings.
SIS files its federal antitrust lawsuit.
After three weeks of trial, SIS stipulates to judgment when the court adopts the disputed instruction.
The Ninth Circuit reverses the judgment and remands the case.
What the Ninth Circuit Actually Decided
The appeals court held that the Kodak/Epic test applies when the primary, or “foremarket,” is competitive and a plaintiff instead claims that customers became trapped in a single-brand aftermarket. It doesn’t apply in the same way when the plaintiff presents evidence that the company already has market power in the primary market.
Here, SIS’s expert placed Intuitive above 99% in the foremarket for minimally invasive soft-tissue surgical robots. Trial evidence placed the company at 100% in the aftermarket for EndoWrists. The Ninth Circuit characterized SIS’s case as a conventional claim that power in one market was used to restrain competition in another.
The distinction matters because information and switching tests accomplish little if buyers lack a meaningful alternative. A hospital can understand every future EndoWrist cost and still be unable to choose another robot if Intuitive effectively controls the available market.
The Ninth Circuit didn’t decide that Intuitive violated antitrust law. It decided that SIS had been required to prove the wrong threshold test.
Intuitive alternatively asked the court to uphold the judgment because, it argued, SIS’s trial evidence was insufficient. The panel rejected that route too.
Intuitive had waived its argument that SIS failed to prove market power before 2019 by not properly raising it before the verdict. The panel added that the evidence would have been sufficient anyway. Intuitive’s own expert testified that the company was approximately the only U.S. seller of these robots from 1999 through 2018, and its president confirmed that it was the only seller until at least 2009.
The court also held that a reasonable jury could find Intuitive’s process for approving third-party EndoWrist services was illusory. SIS presented testimony that no established process existed before November 2022 and noted that earlier third-party approvals involved products such as detergents and instrument trays, not EndoWrists.
Intuitive had contrary evidence. It cited dozens of approved third-party products and services, later approvals involving modified EndoWrists, and the fact that neither SIS nor Rebotix sought approval before the business stopped. That conflict is for a factfinder; the appellate panel didn’t resolve it.
The ruling’s limit
“the evidence presented at trial was sufficient for a reasonable jury to find that Intuitive’s third party approval process was illusory”Ninth Circuit opinion; this is a sufficiency ruling, not a finding that the process was illusory
What Remains Unresolved
- Antitrust liability: No court has determined that Intuitive unlawfully tied products, imposed illegal exclusive dealing or monopolized the EndoWrist aftermarket.
- Competitive effects: A factfinder has not yet resolved whether the contracts and warning letters substantially harmed competition or consumers under the antitrust rule applied to the claims.
- Third-party approval: The record could support a jury finding that Intuitive’s approval route was illusory, but Intuitive presented evidence supporting the opposite conclusion.
- Patient safety: The appellate court expressly took no position on the safety of extended EndoWrist use or the disputed Food and Drug Administration evidence.
- Financial impact: The opinion establishes SIS’s 40% price difference and the loss of six hospital customers, but it doesn’t quantify hospital spending, patient costs or damages.
What to Watch
- The federal district court must determine the next proceedings after the remand. The opinion doesn’t specify a new trial date.
- Intuitive Surgical can continue contesting whether its restrictions harmed competition and whether they were justified by safety or other legitimate considerations.
- SIS still must prove its antitrust claims under the correct legal framework; the reversal restores the case, not a victory on liability.
- Any renewed proceeding will need to keep three questions separate: whether extended use is safe, whether approval was realistically available, and whether the restrictions unlawfully suppressed competition.
The unresolved issue is no longer whether SIS must satisfy a test designed for a competitive robot market. It is whether the contracts, programmed use limits and hospital warnings were lawful restraints in a market where the trial evidence placed Intuitive’s share near total control.
The source document for this investigation is attached below.



