When the Equipment Meant to Help You Causes the Harm
Most people scheduled for a colonoscopy, bronchoscopy, or ERCP are already dealing with enough. A concerning symptom. A worrying diagnosis. The last thing on your mind is whether the device your doctor is using has been properly designed or safely cleaned. You assume that part has been handled.
For thousands of patients across North Carolina that assumption turned out to be dangerously wrong. A design flaw in certain Olympus endoscopic devices allowed harmful bacteria to survive standard sterilization between patients, turning a routine diagnostic or treatment procedure into the starting point of a serious, sometimes fatal, illness.
The FDA did not look the other way. The agency recalled at least five separate Olympus products and eventually issued an import alert blocking more than 50 Olympus devices from entering the United States altogether. Actions of that magnitude do not happen over minor paperwork issues. They happen when a manufacturer has repeatedly demonstrated that its products are putting patients at risk — and has not done enough to stop it.
At Brent Adams & Associates, we have spent more than four decades representing North Carolina families who were hurt by the negligence of others. We are not a national firm parachuting into this state. We are North Carolina lawyers who know these courts, know these communities, and take it personally when our neighbors are harmed by corporate indifference.
The Research Is Clear: This Was a Design Problem, Not a Cleaning Problem
What Makes These Scopes So Dangerous
Flexible endoscopes — and duodenoscopes in particular — have an extraordinarily complex internal architecture. Narrow fluid channels wind through the length of the device. A hinged elevator mechanism at the tip creates tight mechanical crevices. Seals and joints that flex with each use create microscopic gaps where organic material can collect and bacteria can hide.
Standard hospital disinfection procedures were simply not designed to reach these spaces. Research published in Gastrointestinal Endoscopy found that multi-drug resistant bacterial transmission occurred between patients even when hospital staff followed Olympus’s own manufacturer-recommended cleaning instructions without any deviation. That single finding reframed the entire conversation — this was never about negligent hospital workers. This was about a product that was not engineered to be safely reused.
The Association for the Advancement of Medical Instrumentation (AAMI) issued a 2022 report reinforcing exactly that conclusion, finding that flexible endoscopes remain uniquely resistant to adequate disinfection among all medical devices in common use, and that patient safety requires design corrections at the manufacturing level — not more elaborate cleaning checklists.
The Infections That Resulted
The bacteria that survive inside contaminated scopes are not ordinary pathogens. The CDC has directly linked Olympus duodenoscopes to outbreaks of Carbapenem-Resistant Enterobacteriaceae (CRE) — a category of bacteria that resists virtually every antibiotic in the modern clinical arsenal. The CDC classifies CRE as an urgent public health threat and reports mortality rates as high as 50% in vulnerable patient populations.
Documented outbreaks tied to contaminated Olympus scopes resulted in patient deaths at major institutions including UCLA Medical Center and Virginia Mason Medical Center in Seattle. These were well-resourced hospitals with trained infection control teams — and patients still died because the device they were treated with was irreparably flawed.
For North Carolina patients — especially older adults, those undergoing cancer treatment, patients with diabetes or autoimmune conditions, and anyone whose immune system is already under strain — a scope-related infection can escalate rapidly into sepsis, multi-organ failure, extended ICU stays, or death. These are consequences that should never have occurred, and Olympus had the information it needed to prevent them long before many North Carolina patients were harmed.
A Corporate and Regulatory Failure — Year by Year
The FDA began receiving reports linking Olympus endoscopes to patient infections. Separate hospital outbreak investigations around the country started pointing to the same manufacturer without any coordinated public warning being issued.
The FDA released a formal safety communication alerting hospitals to the contamination risks associated with duodenoscopes. Despite this public warning, Olympus continued distributing devices with the same fundamental design without making structural corrections.
A U.S. Senate investigation concluded that Olympus had internal records showing awareness of the contamination problem years before disclosing it publicly. Both the company and the FDA faced sharp criticism for allowing patient harm to continue while moving too slowly to act.
The FDA issued recalls for at least five separate Olympus products as documented patient harm continued to mount. Each recall represented real patients who had already undergone procedures with devices the FDA ultimately determined were unsafe.
The FDA’s decision to block more than 50 Olympus products from entering the U.S. market through an import alert was one of the most aggressive regulatory actions ever taken against a medical device manufacturer — a direct reflection of how serious the ongoing patient safety risk was judged to be.
Federal courts allowed mass tort claims against Olympus to proceed in In re: Olympus Corp. Duodenoscope Products Liability Litigation, recognizing valid legal theories of negligent design, failure to warn, and strict product liability — establishing a framework that benefits injured patients nationwide.
Does Your Situation Qualify?
Qualifying Procedures
Your procedure must have taken place in 2018 or later at a North Carolina hospital, outpatient surgical center, or clinic, and medical records must be obtainable to verify that an Olympus device was used. Covered procedure types currently include:
- Colonoscopy
- ERCP (Endoscopic Retrograde Cholangiopancreatography)
- Upper Endoscopy
- Laparoscopy
- Bronchoscopy
- Ureteroscopy
- Hysteroscopy
- Sinus Endoscopy
- Cystoscopy
If you are unsure which category your procedure falls into, your discharge paperwork, insurance explanation of benefits, or a direct records request to your provider will typically make this clear. Our team can help you determine what to ask for.
Qualifying Injuries
Your injury must have required a separate hospitalization or medical appointment after the procedure. Currently qualifying injuries include:
- Bacterial infection requiring hospitalization within 90 days of the procedure
- Sepsis or bacteremia following the procedure
- Drug-resistant superbug such as CRE or resistant E. coli diagnosed within 180 days
- Pneumonia or severe pulmonary infection within 90 days
- Tuberculosis within 90 days of the procedure
- HIV diagnosis within 90 days of the procedure
- Organ or tissue damage or perforation caused by the device
- Internal burning caused by the device during the procedure
- Device component that broke or dislodged inside the body, requiring additional injury treatment or retrieval surgery
- Qualifying hemorrhage following the procedure
- Death resulting from infection or device component failure
Frequently Asked Questions
Your procedure documentation is the best starting point. Operative notes and device tracking logs maintained by the facility should identify the manufacturer and model of the endoscope used. North Carolina hospitals and licensed surgical facilities are required to maintain these records. A written medical records request submitted to the facility where your procedure occurred will typically include this information. If you received any written communication from your hospital or doctor’s office after your procedure warning of a potential scope contamination issue, that is even more direct confirmation. Our intake team can walk you through exactly what to request.
It matters to your medical history, but it does not close the legal question. The connection between endoscopic procedures and subsequent infections is well-established in the medical literature but is routinely missed — or not disclosed — at the clinical level. Hospitals have not always been forthcoming about linking post-procedure illnesses to specific devices, particularly when doing so might expose them or their equipment suppliers to liability. If your infection developed within the qualifying timeframes and meets the severity threshold, the fact that your physician did not draw the connection does not prevent a legal claim. That is exactly what the review process is designed to sort out.
North Carolina’s wrongful death statute provides a legal avenue for surviving family members when a loved one dies as a result of a defective product or another party’s negligence. If your husband’s infection developed within 90 days of his ERCP procedure and records can confirm an Olympus device was involved, your family’s situation warrants a thorough review. The claim must be brought by the personal representative of the estate under North Carolina law. Our team can explain what that means in practical terms and help you understand your options.
Keep it in a safe place and have it ready when you submit your case evaluation. A written notification from a hospital or from Olympus acknowledging a possible contamination or device failure is one of the most significant pieces of evidence a patient can have. These letters confirm that the facility or manufacturer identified a risk, that your procedure fell within the affected timeframe, and that you were among the patients potentially exposed. In past litigation, these notifications have carried substantial weight in establishing both the scope of the problem and individual patient exposure.
No. Your case evaluation is entirely free and carries no obligation of any kind. If we decide to move forward with your case, we represent you on a contingency fee basis — meaning you owe us nothing unless and until we recover compensation for you. No upfront payments, no retainer fees, no financial risk. Our ability to be paid depends entirely on our ability to deliver results for you.
No, and we want to be clear about that from the start. Submitting your information begins a review process — it does not create an attorney-client relationship or commit either party to anything. Our legal team will carefully evaluate your procedure, your injuries, your medical history, and the other relevant facts before making any decision about representation. We will give you a straight answer about what we find. We do not tell people what they want to hear just to sign them up — we tell them the truth.
Current qualifying criteria focus on procedures from 2018 forward. However, the date your injury was discovered — which may differ meaningfully from the date of your procedure — can affect how legal deadlines are calculated under North Carolina law. We encourage you to submit your information and let our team assess your specific facts before drawing any conclusions about eligibility.
Brent Adams & Associates Is Ready to Fight for North Carolina Families
North Carolina patients walked into hospitals and clinics trusting that their care was safe. Olympus — through deliberate design choices and a years-long failure to adequately warn patients and providers — violated that trust. The FDA’s actions, the Senate’s findings, and federal court rulings all confirm what injured patients have known firsthand: this was preventable, and someone should be held accountable.
Brent Adams & Associates has been a fixture in North Carolina law for more than four decades. We have handled serious injury and product liability cases across Charlotte, Raleigh, Durham, Greensboro, Winston-Salem, Wilmington, Asheville, Fayetteville, and every region of this state. We do not hand cases off to strangers or treat clients as case numbers. We fight hard, we stay involved, and we do not stop until our clients get the outcome they deserve.
Your evaluation is completely free. If we take your case, you pay nothing unless we win.