Duodenoscope Infection Lawsuit – Submit an ERCP Claim [2026 Update]

The Duodenoscope Lawsuit is an Active Lawsuit

See if You Qualify

People have experienced serious infections after having an ERCP procedure with a duodenoscope. In turn, some patients are filing duodenoscope infection lawsuits because they believe their infections were caused by bacteria in the scopes. According to lawsuits and FDA investigations, the way some duodenoscopes are designed allows bacteria to remain in the device, even after it is cleaned.

Below, you will find information on duodenoscopes, ERCPs, how infections occur, which duodenoscope models have been associated with contamination, and what types of infections patients are experiencing. This page also discusses:

• Who qualifies to file a lawsuit if they or their loved one suffered from a duodenoscope-related infection (including a superbug infection)
• How to file an ERCP infection claim
• What compensation someone might receive from a duodenoscope infection lawsuit

This page is part of King Law’s broader investigation into Olympus scope lawsuits, including colonoscopy infection claims and post-endoscopy infection claims. Olympus’ scopes have been the subject of recalls, warning letters, and investigations.

About the Duodenoscope Infection Lawsuit

Duodenoscope Lawsuit Updates and FDA Safety Warnings (2026)

The FDA and Olympus have been monitoring infection rates associated with duodenoscopes for over a decade. FDA action has prompted some duodenoscope manufacturers to change their products’ design. People have also filed lawsuits after they or their loved ones suffered a severe duodenoscope-related infection.

March 19, 2026: Washington Woman Sues Duodenoscope Maker Olympus After Contracting Superbug

A woman from Washington has filed a lawsuit against Olympus, the company that makes duodenoscopes and other medical scopes. According to her legal filings, she claims she contracted a severe and unexpected superbug after having an ERCP procedure done with a duodenoscope made by Olympus. Her lawsuit alleges that the way Olympus’s reusable duodenoscopes are designed prevents hospitals from sanitizing them, allowing bacteria to be transmitted from one patient to another. Her legal complaint accuses Olympus of not using a safer design for its duodenoscopes and failing to warn people about the risks.

October 14, 2025: Field Notice Sent to Doctors, Warning of Infection Risks Associated with Duodenoscopes used in ERCPs

Olympus issued a field notice to doctors and hospitals that may have purchased its duodenoscopes . The notice explained that the Evis Exera III Duodenoscope (Model Number TJF-Q190V) may be associated with patient infections from bacteria left in the device after cleaning, even when cleaning follows existing guidelines. These scopes are primarily used in endoscopic retrograde cholangiopancreatography (ERCP) procedures.

April 5, 2022: FDA Recommends Companies Change Design of Duodenoscopes to Lower Infection Risks

The FDA issued a safety communication on April 5, 2022, encouraging duodenoscope manufacturers to transition to removable or single-use parts. The FDA suggested the current design of reusable duodenoscopes makes it possible for bacteria to become trapped in the scope and then be transmitted from one patient to another. According to the notice, the FDA says that using removable parts may help hospitals thoroughly disinfect the duodenoscope and decrease infection rates.

July 24, 2020: FDA Warns of Bacterial Contamination with Fixed Endcap Endoscopes

The FDA issued a safety communication about a higher risk of infection associated with reusable fixed endcap endoscopes versus those with disposable pieces. According to the FDA’s announcement, the design of some fixed endcap endoscopes allows bacteria to become trapped in small crevices that are hard to clean. Even organizations that use ethylene oxide or other standard medical sterilization methods may not remove bacteria from small parts, such as end caps. Because of this, the FDA recommended that companies transition to removable, single-use endcaps.

December 10, 2018: Olympus and Its Former Executive Plead Guilty to Selling Defective Duodenoscopes and Not Reporting Adverse Events

Olympus pleaded guilty to charges that it continued to sell duodenoscopes even though it did not report many infection-related adverse events to the FDA. According to the US Attorney General’s Office, Olympus and its executive had also been contacted by a reputable scientist who was concerned about the safety of the duodenoscope. Even so, Olympus and its former executive did not tell the FDA about 30 infections that occurred in patients after they had duodenoscope procedures done. Olympus was fined about $80 million, and its former executive was also fined and sentenced to jail.

January 8, 2016: Olympus Announces Class 2 Recall of Evis Exera II Duodenovideoscope Olympus TJFQ180V

Olympus issued a Class 2 recall of its Evis Exera II Duodenovideoscope. The model number for this device is Olympus TJFQ180V. The device is used to assist doctors in performing operations and to view parts of the patient’s body using the device’s side-viewing cameras. The recall instructs doctors to replace the old forceps on the device with a newer model.

What Is a Duodenoscope and What Is It Used For?

Duodenoscopes are reusable endoscopes used by doctors to diagnose and treat conditions, including those involving the pancreas, gallbladder, and bile ducts. A duodenoscope is a flexible endoscope that the doctor puts into the patient’s body (e.g., through their mouth or nose) and moves through their digestive tract.

Duodenoscopes typically contain tiny tools that doctors can use to take pictures, collect biopsies, administer medications, and perform some procedures. A duodenoscope is often put into the patient during an endoscopic retrograde cholangiopancreatography (ERCP) procedure. The device’s camera is used to view different parts of the patient’s body.

What Is an ERCP Procedure?

Duodenoscopes are typically used to perform an endoscopic retrograde cholangiopancreatography (ERCP) . An ERCP is a medical procedure that uses a duodenoscope to diagnose and treat conditions involving the bile ducts, pancreas, and gallbladder. For instance, ERCP procedures may be used to:

• View a patient’s pancreas, bile ducts, or gall bladder
• Remove masses, stones, or obstructions
• Take a biopsy
• Give the patient medications
• Perform procedures
• Place stents

Some studies estimate that about 650,000 ERCPs are performed each year in the United States (as cited in “Global trends of ERCP research in the last 25 years: A bibliometrics study”). One of the possible complications of an ERCP procedure is a bacterial infection.

Why Are Some Duodenoscopes Linked to Infections After an ERCP?

Duodenoscopes may be linked to a higher risk of infection because they have many tiny parts that are hard to disinfect. According to a paper called “ Current Issues in Duodenoscope-Associated Infections: Now Is the Time to Take Action ,” bacteria can get trapped in the tiny crevices of the duodenoscope’s mechanical parts, like the forceps, elevator, or fixed caps.

According to some public reports, bacteria may survive on the duodenoscope even if the hospital follows the manufacturer’s and FDA’s cleaning (reprocessing) guidelines. When bacteria stay in the duodenoscope, they can infect the next patient treated with that same duodenoscope.

Why Are Duodenoscopes Difficult to Sterilize?

A duodenoscope is a complex medical device, containing small parts and a complex design. According to the study above, two of the components that are difficult to sterilize are the elevators and elevator channels. These parts are usually scrubbed manually with a solution, but these practices do not always remove all of the bacteria.

Additionally, some bacteria may form biofilms, making removing them from duodenoscopes even more difficult. Some bacteria form a substance called a biofilm, which can make the bacteria resistant to antibiotics, disinfectants, and biocides. According to a study published in the journal Endoscopy, bacteria in a duodenoscope’s inner channels are able to form biofilms, making the devices even more difficult to properly clean and reprocess.

Are Olympus’ Duodenoscopes Part of a Design Defect Litigation?

Some of Olympus’ duodenoscopes are the subject of recalls, warnings, and lawsuits. Research and lawsuits allege that certain components of these scopes are very difficult to clean and harbor bacteria. Lawsuits argue that making a medical device that cannot be properly sterilized means that the device has a design defect. Pending and future litigations will likely cite this design flaw and accuse the companies of not taking the proper actions regarding defects.

What Do Medical Studies Show About Duodenoscope Contamination and ERCP Infection Risk?

Multiple medical studies have suggested that patients may have an increased risk of infection if their doctor uses some types of duodenoscopes. For example, one meta-analysis suggested that duodenoscopes have a 15.25% risk of contamination (as cited in “Rate and impact of duodenoscope contamination: A systematic review and meta-analysis”).

That same study noted that even using ethylene oxide or other high-standard sterilization methods did not completely remove the risk of contamination.

Another study noted that duodenoscopes carry a “high rate of infection,” potentially due to the design of the endoscope (as cited in “Unveiling 8 years of duodenoscope contamination: insights from a retrospective analysis in a large tertiary care hospital”).

The researcher who published that study suggested that some of the duodenoscopes’ components (like the biopsy and suction channels) are “especially” hard to clean and disinfect. The researchers encouraged companies to change the way the duodenoscopes are designed to make them easier to clean.

How Often Do Duodenoscope Infections Occur After an ERCP?

Although duodenoscope-related infections are relatively uncommon, some researchers have found that infections may occur after 0.4 to 1% of procedures. Another study, published in the journal Endoscopy, suggested that about 9% of duodenoscopes cleaned using double high-level disinfection protocols may still be contaminated with microorganisms.

Another study found data that postprocedure bacteremia (post-surgical infections) may occur 6.4 to 18% of the time when duodenoscopes are used for an ERCP (as cited in: “Duodenoscope-Acquired Infections: Risk Factors to Consider”).

Other researchers have suggested that infections related to duodenoscopes may be underreported (as stated in “Duodenoscope-associated infection prevention: A call for evidence-based decision making”). Those scientists suggest that the significant delay between when a patient undergoes a procedure using a duodenoscope and when the signs of an infection appear may result in underreporting. Patients may not be connecting their infections to their scoping procedures.

Further, the researchers believed that only serious or drug-resistant infections may be reported. So, doctors either may not realize the infection is related to the duodenoscope or they may not report it because it is not likely to pose a serious risk to the patient.

What Types of Infections Have Been Linked to Duodenoscopes?

Duodenoscopes have been found to introduce pathogens into some patients’ digestive systems. Some studies have found that duodenoscopes may be associated with a higher risk some types of infections, including:

• Carbapenem-resistant Enterobacteriaceae (CRE)
• Klebsiella pneumoniae
• Escherichia coli
• Methylobacterium mesophillicum
• Pseudomonas aeruginosa
• Sepsis and bloodstream infections

Some of these infections may be caused by drug-resistant bacteria (e.g., superbugs or Carbapenem-resistant Enterobacterales [CRE]), which can pose serious risks and even result in death. After people are exposed to some types of bacteria, they can develop sepsis. Sepsis is a life-threatening condition that can lead to organ failure.

What Caused the Duodenoscope Infection Outbreaks?

In some cases, there have been multiple infections linked to the same endoscopic device, hospital, or surgical center. Some of the reasons that duodenoscope infections may have occurred include the following:

• The device’s complex design makes it hard to disinfect.
• Clinicians did not properly clean or dry the duodenoscope.
• The device becomes worn or damaged.
• The device picks up bacteria or organic waste during storage or handling.
• Bacteria are transferred to the patient from stents or other medical supplies used during the ERCP.

According to public reports, at least one duodenoscope manufacturer may have known about a possibly high infection rate but did not inform consumers or the FDA.

Notable Infection Outbreaks Linked to Contaminated Duodenoscopes

Duodenoscopes have been linked to multiple outbreaks of antibiotic-resistant infections. For example, between January 2000 and December 2017, in the U.S. and Europe, there were at least 32 known infection outbreaks linked to closed-channel duodenoscopes. These outbreaks occurred at at least 45 medical sites and affected at least 400 patients.

In July 2015, the CDC investigated a CRE outbreak at the University of California, Los Angeles (UCLA) Medical Center. This investigation focused on CRE transmission through improperly sterilized duodenoscopes used during ERCP procedures.

In a 2013 outbreak, 39 patients at a tertiary care hospital in northeastern Illinois developed New Delhi metallo-β-lactamase (NDM), associated with contaminated duodenoscopes.

Which Duodenoscope Manufacturers Are Named in Lawsuits?

Some duodenoscope infection lawsuits accuse the following manufacturers of failing to warn patients and doctors about the risks of infection:

• Olympus Corporation (including Olympus TJF-Q180V duodenoscope
• Olympus TJF-160 series models)
• Pentax Medical
• Fujifilm Medical Systems

Olympus duodenoscopes have been linked to at least one outbreak. Olympus faces several lawsuits over its alleged failure to warn patients and medical professionals about the potential risks of infection associated with their devices.

Olympus, Pentax, and Fujifilm Duodenoscopes and Infection Lawsuits

The duodenoscope models under scrutiny include those made by Olympus, Fujifilm, and Pentax. Scientific studies suggest that some reusable duodenoscopes may still be contaminated, even when disinfecting protocols have been followed. Some members of the medical community and researchers believe this is because the duodenoscope’s complex design may make it difficult to fully disinfect all the components.

Duodenoscope infection lawsuits have been brought against Olympus, focusing on its TJF-Q180V and TJF-160 series. According to FDA post-marketing data, some models of Olympus’ duodenoscopes had concerning contamination rates. For example, inspection results for TJF-160F/VF duodenoscopes found that 6.6% of the scopes tested positive for “high concern organisms” after going through the reprocessing/disinfection process.

The FDA indicated that many of these duodenoscope infections occurred even though hospitals followed industry and manufacturer guidelines for cleaning and disinfection. Some lawsuits against Olympus accuse the company of failing to warn patients and their doctors that the duodenoscope’s design features may make it difficult or nearly impossible to fully disinfect.

Pentax and Fujifilm also manufactured duodenoscopes, and some of their models may have been associated with infections. However, the FDA reported that newer models for these duodenoscopes carry minimal or no risk of contamination when used and cleaned according to the manufacturer’s instructions. For example, Fujifilm’s newer duodenoscope uses a disposable endcap, which may greatly reduce the risk of contamination.

What Did the FDA Say About Duodenoscope Infections?

The FDA has issued multiple safety communications about duodenoscope contamination rates and infection risks. For example, in February 2015, the FDA warned that duodenoscopes used for ERCP procedures may become contaminated because their complex design makes them harder to disinfect.

This prompted the FDA to require some duodenoscope manufacturers to participate in a post-market surveillance study (called the 522 study). Based on those studies, the FDA ordered the companies to change how the duodenoscope is cleaned or designed. For instance, the FDA required the companies to remove fixed endcap duodenoscopes from the market. The FDA asked the companies to conduct more research to make sure the contamination rate went down over time.

What Are the Symptoms of an Infection after an ERCP?

Some of the symptoms of an infection after undergoing a duodenoscope ERCP procedure include:

• Fever
• Chills
• Abdominal pain
• Nausea or vomiting
• Jaundice
• Sepsis
• Bloodstream infections
• Breathing problems
• Dark or tarry stools
• Inflammation

The symptoms of a duodenoscope-related infection may appear days, weeks, or over a month after the patient has an ERCP. Patients who get sick or develop an infection after a duodenoscope procedure should tell their medical providers right away.

Who Can File a Duodenoscope Infection Lawsuit?

Our firm is using the following eligibility criteria to determine if someone may file a duodenoscope infection lawsuit:

• The person had a procedure that used a duodenoscope (e.g., an endoscopic retrograde cholangiopancreatography procedure).
• The person developed a severe infection that required intensive treatments (like intravenous antibiotics).
• The person had not gotten a severe infection within a year before.

Family members may also be able to file a claim if their loved one allegedly died because of a duodenoscope-related infection.

You may still be able to file a lawsuit even if you do not meet the above criteria. Our firm intends to update our eligibility requirements as the duodenoscope infection lawsuits progress. You can find out if you qualify to file a duodenoscope lawsuit by calling our law firm directly.

What Evidence Is Needed for a Duodenoscope Lawsuit?

Evidence you can use to support your duodenoscope lawsuit includes the following:

• Records showing you had an endoscopic retrograde cholangiopancreatography procedure with a duodenoscope
• Reports proving you developed a severe infection afterward
• Test results showing what kind or kinds of bacterial infections you suffered from
• Records showing what kind of duodenoscope model was used
• Medical bills, insurance statements, and treatment records

Your attorney can help you identify and gather robust evidence to support your duodenoscope infection lawsuit.

How Can I File a Duodenoscope Infection Lawsuit?

Filing a duodenoscope infection lawsuit involves the following steps:

1. Talking to a law firm about your duodenoscope infection claim during a free case evaluation.
2. Gathering medical records to prove that you had a procedure with a duodenoscope and developed an infection afterward.
3. Collecting documents to prove the cost of the diagnosis, treatment, and related medical expenses.
4. When the time is right, your attorney prepares and files a legal complaint against the company that manufactured the duodenoscope.
5. Your legal team guides negotiation discussions with the duodenoscope manufacturer.
6. Your attorney presents your duodenoscope infection case for trial if settlement discussions are unsuccessful.

Many attorneys handle duodenoscope infection lawsuits on a contingency basis, meaning clients may not have to pay any upfront legal fees. Instead, the lawyer would only receive a set percentage of the client’s final settlement if the attorney wins the client’s case for them.

What Compensation May Be Available in a Duodenoscope Lawsuit?

Compensation that may be available in a duodenoscope infection settlement includes the following:

• Costs of diagnosing, treating, and monitoring the duodenoscope-related infection
• Medical expenses
• Lost income
• Lost earning potential
• Loss of quality of life
• Pain and suffering
• Wrongful death damages, if applicable

Someone’s final payout depends on many factors, including the severity of the person’s injuries, the strength of their claim, and whether they file before the statute of limitations expires.

King Law Is Investigating Duodenoscope Infection Claims and ERCP Infection Lawsuits

King Law is investigating claims that a contaminated duodenoscope used during an ERCP or similar procedure may have caused someone to develop an infection. People who developed CRE, sepsis, or other serious infections after an ERCP procedure may qualify to request compensation in a duodenoscope claim. Reach out to our firm today to schedule a free duodenoscope infection case review so we can help you protect your legal rights before the filing deadline expires.

King Law is also investigating broader claims about infections after endoscopic procedures. Learn more about litigation involving contaminated endoscopes on our Olympus scopes lawsuit page. If you developed an infection after a colonoscopy, you can visit our colonoscopy lawsuit page.

Contact a Duodenoscope Infection Lawyer

Call King Law today by dialing (585) 496-2648 to schedule a free consultation to discuss your potential duodenoscope infection lawsuit. We can also be reached online. Our consultations are free, no-obligation, and confidential. We have a robust network of resources to help us develop a strong duodenoscope infection claim on your behalf.

Frequently Asked Questions (FAQs)

Sources Used In This Article

Here is a list of sources used to generate this content.

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