Robotic Surgery and Medical Negligence Claims

Robotic surgery is increasingly becoming a standard feature in many major Irish hospitals and specialist centres as surgical teams embrace the next generation of minimally invasive techniques. A recent national guidance document published by the Royal College of Surgeons in Ireland outlines new standards for clinical governance, training, and outcomes monitoring.

As the use of robotic platforms increases, the legal landscape surrounding operational risks, device regulation, and clinical accountability is evolving. For anyone considering a claim following a robotic procedure, it is helpful to understand how the regulatory frameworks, clinical governance standards, and duties of informed consent apply in practice.

What is robotic surgery?

Robotic surgery, sometimes called robot-assisted surgery, is a form of minimally invasive surgery where the surgeon operates using a computer-controlled robotic system. The technology allows the surgeon to make very precise movements through small incisions, while viewing the surgical area in high definition on a console screen. The robot’s instruments can move with greater flexibility than the human hand, enabling delicate procedures to be carried out with a high level of control.

These systems are not autonomous. Every movement of the robot’s arms is directed by the surgeon in real time. The technology is designed to enhance, rather than replace, surgical skill. In Ireland, robotic systems such as the da Vinci platform are now used in procedures including prostate, colorectal, gynaecological and kidney surgery, with further expansion into other specialties expected.

Advocates highlight benefits such as smaller incisions, reduced blood loss, and faster recovery times. However, the use of complex equipment introduces additional considerations for patient safety, staff training, and maintenance. As the technology becomes more common, hospitals are expected to follow national guidance to ensure that every robotic procedure is carried out under proper governance and oversight.

How robotic surgery is regulated in Ireland

Robotic surgery involves both medical professionals and complex technology, so it falls under several overlapping areas of regulation in Ireland. These rules aim to make sure that robotic systems are safe, properly maintained, and used only by trained professionals working within approved governance structures.

At present, the main elements of regulation are:

• Medical device safety – Robotic surgical systems, such as the da Vinci platform, are classified as medical devices under the EU Medical Devices Regulation (MDR) 2017/745. In Ireland, this law is enforced by the Health Products Regulatory Authority (HPRA), which oversees compliance with MDR, including market surveillance, registration, and incident reporting.
• Hospital governance – Hospitals and surgical centres must ensure appropriate supervision, training, and audit processes for robotic surgery. The RCSI has published Robotic Surgery Governance in Ireland: A Guide to Good Practice, setting national standards for governance, credentialing, and data monitoring.
• Professional regulation – Surgeons remain accountable under the Medical Practitioners Act 2007 and the Medical Council’s standards of competence. They must be properly trained and credentialed before performing robotic procedures.
• Artificial intelligence and software – Where a robotic system incorporates decision-support software or automation, it may also fall under the EU Artificial Intelligence Act, which often categorises such systems as high-risk AI. This requires strong safeguards, transparency, and human oversight.

Together, these frameworks are designed to protect patients and ensure consistent standards of care. When something goes wrong during robotic surgery, these same rules can be important in determining whether proper procedures were followed and whether a claim for medical negligence might arise.

The legal test for negligence in robotic surgery cases

The law does not treat robotic surgery as a special category of medical practice. The same legal principles apply as in any other case of alleged medical negligence. Because robotic procedures involve advanced technology and specialist training, the evidence used to assess a claim may be more technical, but the test itself remains unchanged.

The key precedent is the Supreme Court case Dunne v National Maternity Hospital [1989] IR 91. It established that a medical professional is negligent if they act in a way that no reasonable clinician of equal skill and standing would have acted, having regard to accepted practice at the time. A practice followed by a responsible body of practitioners is generally not considered negligent unless it is clearly indefensible.

In a robotic surgery case, the court may look at:

• Whether the surgeon had appropriate training, credentialing, and supervision before performing robotic procedures.
• Whether the hospital had robust governance arrangements, consistent with national guidance such as the RCSI’s Guide to Good Practice.
• Whether there were adequate systems for equipment maintenance, troubleshooting, and emergency conversion to open surgery if needed.
• Whether the patient provided informed consent, having been told the procedure would be performed using a robotic system and being made aware of the relevant risks and alternatives.
• Whether any device malfunction or software error was foreseeable or could have been prevented through reasonable care.

Expert medical and technical evidence will usually be needed to determine what a competent surgeon or hospital should have done in the circumstances. The court will then decide whether the care fell below the standard expected of a reasonably competent professional and whether that failure caused the patient harm.

In short, while robotic surgery introduces new technology into the operating theatre, the fundamental legal question remains the same: was the care reasonable, safe, and in line with accepted professional standards?

When might a patient have a claim?

Most robotic procedures in Ireland are performed safely and successfully. However, as with any medical treatment, things can go wrong. Some examples of where a patient may have grounds for a medical negligence claim include the following:

• Inadequate training or supervision – If a surgeon performs robotic surgery without sufficient training, supervision, or proctoring, complications may occur that would likely have been avoided with appropriate experience or oversight.
• Poor hospital governance – Failure to maintain proper governance, audit, and maintenance systems could amount to negligence at an organisational level.
• Lack of informed consent – Patients must be told that the procedure will be performed using a robotic system and given a clear explanation of the potential risks, benefits, and alternatives. If this information is not properly communicated, the consent process may be legally invalid.
• Equipment malfunction or misuse – Mechanical or software failures during surgery can lead to injury. A claim might arise if the fault was known or should have been detected through regular inspection, maintenance, or training. Some cases may also involve product liability if the robot or one of its components was defective.
• Failure to act on complications – Delays in recognising or responding to post-operative problems such as bleeding, infection, or organ injury may also give rise to a negligence claim.

Considering bringing a claim?

If you have concerns about the outcome of a robotic surgery or believe that mistakes were made during your treatment, it may help to discuss your experience with a solicitor who specialises in medical negligence. The team at McCarthy + Co Solicitors LLP has extensive experience in complex surgical and medical claims. Arrange a no-obligation consultation with a solicitor here by completing our quick and confidential online form.