Defective Surgical Instrument Claims

Surgery is never an easy decision. Whether planned or urgent, you put your trust in the hospital, the surgical team, and the tools they use. But sometimes, things go wrong—not because of the skill of the surgeon, but because the instruments themselves were faulty. That can be a hard truth to face, especially when you’re left with pain, complications, or a longer recovery than expected.

At John O’Leary Solicitors LLP, we’ve stood beside people across Tallaght and Dublin for over 20 years—people who’ve woken up after surgery only to find something wasn’t right. Maybe a tool broke during the procedure. Maybe an instrument hadn’t been sterilised properly. Or maybe a defective device caused avoidable injury that no one explained at the time.

We know the system, but more importantly, we know how to listen. You won’t be brushed off or told it’s “just one of those things.” You’ll speak to a solicitor who understands what’s involved in these types of claims and who’ll take the time to explain your rights clearly, without the jargon.

If you’re dealing with the effects of a surgical complication caused by a faulty or misused instrument, you don’t have to figure it all out alone. Contact us to get started.

What Happens When Surgical Instruments Fail?

Defective surgical instruments can cause a range of adverse outcomes during or after a procedure. These consequences fall into four core categories:

Intraoperative Complications

Defective instruments can cause direct harm during surgery:

  • Tissue damagedue to broken or misaligned tools (e.g. blades, drills, clamps)
  • Bleeding or haemorrhagefrom failed cauterisation or sharp instrument failure
  • Instrument breakagerequiring urgent removal of fragments or conversion to open surgery
  • Extended operating time, increasing anaesthetic risk and exposure to infection

Instruments used in robotic or laparoscopic surgeries may fail mid-procedure, requiring conversion to manual surgery—prolonging the operation and recovery.

Retained Foreign Objects

Some defects result in parts of instruments being left behind:

  • Broken tips, screws, or metal shavingscan remain unnoticed
  • Non-detectionmay arise from faulty counting/tracking systems
  • Subsequent injuryincludes chronic pain, infection, abscess formation, or need for additional surgery

Retained surgical items can also lead to sepsis, organ injury, or long-term mobility issues, depending on the location and duration of retention.

Postoperative Infection and Delayed Healing

Contaminated or unsterilised instruments can introduce pathogens during surgery. This can result in:

  • Surgical site infections (SSIs)requiring antibiotics or wound reopening
  • Systemic infections, including bacteraemia or sepsis
  • Implant failure, where contamination affects prosthetic integration
  • Extended hospitalisation and readmission

These outcomes often delay discharge, increase follow-up costs, and may limit physical rehabilitation options.

Secondary Surgery and Compounding Harm

In cases of confirmed failure:

  • Revision proceduresmay be required to remove retained parts or correct surgical errors
  • Scarring or structural damagemay be more extensive due to additional operations
  • Permanent deficits, such as nerve injury or loss of function, can arise from tissue disruption or improper instrument use

Secondary surgery increases patient exposure to risk, emotional stress, and recovery burden.

Defective instrument claims are distinct because they stem from product failure, not poor surgical skill.

What Can Go Wrong: Common Defects and Failures

Surgical instrument failures are rarely the result of a single mistake. Most trace back to a problem in design, manufacture, handling, sterilisation, or integration with hospital systems. Understanding these causes is essential to determining whether a product defect or liability issue has occurred.

Manufacturing Defects

Instruments that are improperly constructed or assembled during the manufacturing process may:

  • Contain hairline fractures, weak joints, or inconsistent welds
  • Include contaminantsfrom production environments (e.g. metal shavings, lubricants)
  • Use substandard materials, such as low-grade alloys or plastics that can’t withstand sterilisation

These faults may not be visible to the naked eye but often emerge during use, especially under stress.

Design Flaws

Some instruments are inherently prone to failure due to poor design:

  • Locking mechanismson clamps or forceps that don’t hold under tension
  • Inadequate ergonomic shaping, which leads to excess force during handling
  • Components with unintended pressure points, making them more likely to snap, bend, or stick
  • Reusable tools that degrade faster than intended, despite meeting basic cleaning guidelines

Design issues often lead to product recalls when patterns of failure are identified post-distribution.

Packaging and Labelling Errors

Errors at the packaging stage can render even a well-designed tool dangerous. Common problems include:

  • Incorrect or incomplete labelling(e.g. wrong size, batch, or expiry date)
  • Damaged sterile barriersthat allow microbial contamination
  • Mismatched contents, where the packaging doesn’t match the tool inside

These faults increase the risk of contamination or misuse in theatre settings.

Sterilisation and Reprocessing Failures

Instruments are often cleaned and reused multiple times. Failures here are typically caused by:

  • Autoclave malfunctions(e.g. incorrect temperature or cycle duration)
  • Overloaded sterilisation trays, preventing full decontamination
  • Wear and tearnot identified during inspection
  • Residue build-up, especially on tools with complex internal channels

Where central sterilisation services are outsourced, failure may also occur due to contractor error or traceability gaps.

Supply Chain Contamination or Damage

Even after production, instruments may become defective before reaching the hospital:

  • Poor storage conditions can cause corrosion or rusting
  • Exposure to high humidity or incorrect handling during shipping
  • Cross-contaminationduring unpacking or tray assembly in hospital stores

These faults often go undetected until theatre use, where signs of failure emerge too late.

System Integration Failures (Tracking & IT)

Modern surgical settings use digital tracking systems to account for every instrument. Failures in this layer can lead to:

  • Incorrect item counts, resulting in retained items
  • Unlogged substitutionsof recalled or expired instruments
  • Failure to trigger alerts for recalled batchesalready in circulation

These errors may implicate hospitals, software vendors, or tracking equipment suppliers—not just manufacturers.

Legal Grounds for a Defective Surgical Instrument Claim

When a surgical instrument fails and causes injury, the question becomes whether there are legal grounds to bring a claim. In Ireland, these claims are typically pursued under product liability law, not medical negligence. That means the focus is on the safety and integrity of the instrument itself—not the performance of the surgical team.

Strict Liability Under the Liability for Defective Products Act, 1991

Under this legislation, a person injured by a defective product does not need to prove negligence. Instead, they must prove:

  1. The product was defective
  2. The defect caused damage or injury
  3. The product was used as intended or reasonably foreseeable

A surgical instrument is considered defective if it fails to meet the level of safety the public is entitled to expect. This includes failures due to:

  • Manufacturing defects (e.g. fractured drill heads, sharp fragment release)
  • Sterilisation or contamination issues
  • Mislabelling, expired products, or defective tracking systems

Who Can Be Held Liable?

Responsibility may lie with one or more of the following parties:

  • The manufacturerof the instrument or device
  • The supplier or distributorthat imported or sold the item
  • The hospital or clinic, if they failed to inspect, sterilise, or safely track instruments
  • A third-party sterilisation provider, where applicable

Liability may also extend to software or digital tracking system providers, if an automated count failure led to a retained instrument or critical safety lapse.

How Is Liability Proven in Practice?

While you don’t need to prove intent or fault, you do need to show causation—that is, that the defect directly caused your injury. This is typically done using:

  • Operative reportsand surgical notes
  • Device batch numbersand tracking logs
  • Sterilisation records
  • Consultant opinionsthat support a link between the product failure and the resulting harm

We also examine whether the instrument was subject to a recall, safety alert, or known failure trend, which may support the claim.

When Is the Hospital Liable?

If the instrument was handled correctly but failed due to a defect, the hospital may have no direct liability. However, if the issue involved:

  • Use of an expired or recalled product
  • Failure to detect damage prior to use
  • Faulty sterilisation or tray preparation
    Then the hospital may also be held accountable under general negligence law.

Establishing the legal basis for your claim depends on clear documentation, timelines, and product records.

Time Limits and Legal Risks in Surgical Tool Claims

Claims involving defective surgical instruments are subject to specific time limits under Irish law. Missing these deadlines can result in your case being struck out, no matter how strong the evidence may be.

Three-year Time Limit from Date of Knowledge

Under the Liability for Defective Products Act, 1991, you have three years to bring a claim. This period typically begins on the date you became aware—or ought to have become aware—that the surgical instrument may have caused your injury.

This doesn’t always align with the date of surgery. In some cases, the defect may only become apparent weeks or months later—for example, when a retained fragment is discovered, or a post-surgical infection is traced back to a contaminated tool. The clock starts when the cause of injury becomes reasonably clear to the patient.

Ten-year Long Stop from Date of Product Circulation

Even if you only became aware recently, there’s a hard 10-year cap on bringing a claim. This period is measured from the date the specific product or batch was first placed on the market—not the date it was used in your operation.

This is known as the long stop rule. Once 10 years have passed from the product’s release, the law prohibits any claim—even if the defect was discovered later and clearly caused your injury.

Risks of Delaying a Claim

Failure to act within the above limits carries several consequences:

  • You lose your right to bring a claim entirely
  • Important evidence such as the instrument itself, its batch number, or sterilisation records may be lost or disposed of
  • Hospitals may no longer retain surgical footage or theatre logs, especially after routine timeframes lapse
  • Manufacturers may argue the injury arose from unrelated surgical factors, and you’ll have fewer documents or expert reports to rebut their position

For these reasons, early legal advice is recommended and often essential to protecting your right to take action.

Frequently Asked Questions

How do I know if a surgical instrument caused my complications?

In many cases, patients aren’t told outright that an instrument failed. Clues often come from post-op records, unexplained complications, or prolonged recovery. If you experienced unexpected infection, nerve damage, a return to theatre, or were told your surgery “didn’t go as planned,” it may be worth investigating. Your solicitor can request and review your medical records and surgical notes to identify any mention of equipment failure or theatre incidents.

Can I still bring a claim if no one told me about the issue at the time?

Yes. Many people only find out months—or even years—later that something went wrong with a surgical instrument. You don’t need to have been informed immediately. What matters is when you became aware, or should reasonably have become aware, that your injury may have been caused by a defective device. That’s when your legal time limit begins. A solicitor can help assess whether you’re still within the relevant timeframe.

What if my surgery took place in a private hospital?

You can still make a claim. Product liability law applies regardless of whether your procedure took place in a public hospital, private clinic, or specialist surgical centre. The key factor is whether the injury was caused by a defective instrument—not where the surgery happened. If you were treated in a private facility, we can still obtain records and determine who is legally responsible.

Is the hospital responsible, or the company who made the tool?

It depends on the cause of the failure. If the instrument was defective due to how it was made, the manufacturer or distributor may be liable. If the problem arose from improper sterilisation, expired tools, or use of a recalled product, the hospital or its service providers may also bear responsibility. Some cases involve shared liability between multiple parties. We’ll investigate the source of the defect and advise you accordingly.

Will I need to go to court to bring a claim?

Not necessarily. Many defective product claims are resolved through negotiation without ever reaching a courtroom. However, if the case is complex or strongly contested, it may need to proceed to litigation. In that case, we’ll prepare thoroughly, guide you through the process, and make sure you’re fully supported at every stage. Our goal is to keep the process as straightforward and stress-free as possible while protecting your interests.

Contact a Local Solicitor Who Will Handle This Personally

If you’ve experienced complications after surgery and suspect a defective instrument may be to blame, it’s worth getting clear, honest advice. At John O’Leary Solicitors LLP, you’ll speak directly with a solicitor who understands these cases and the legal framework around them. We’ve supported individuals across Tallaght and Dublin for over 20 years. Contact us by phone, email, or visit our office to discuss your concerns in confidence.