Olympus Scope Infection Concerns Follow Years of FDA Warnings Over Reusable Endoscopes

Following more than a decade of warnings about Olympus scope infection problems that may allow bacteria to be transferred between patients, lawsuits now claim manufacturers failed to address the contamination risks.

Federal regulators have warned for years that certain medical scopes used during colonoscopies and other endoscopic procedures may be difficult to fully clean between patients, and Olympus now faces claims that it knew about infection risks linked to it’s devices, but continued to distribute reusable scopes without adequate reprocessing steps.

The devices are commonly used during procedures such as colonoscopy, endoscopy, bronchoscopy, cystoscopy and endoscopic retrograde cholangiopancreatography (ERCP) procedures, allowing doctors to diagnose and treat conditions involving the digestive tract, lungs, urinary tract, bile ducts, pancreas and other internal areas.

The FDA indicates that duodenoscopes alone are used in more than 500,000 ERCP procedures each year in the United States, with millions of colonoscopies performed for routine screening among individuals over the age of 50.

Given that Olympus and other manufacturer duodenoscopes are intended to be reused on multiple patients, they must be thoroughly cleaned, disinfected or sterilized before each procedure. However, regulators have warned that some devices contain narrow channels, moving parts and hard-to-inspect areas where tissue, fluid or bacteria may remain after reprocessing.

If bacteria survive inside a scope after reprocessing, the device may appear clean but still carry infectious material into the next procedure. That creates a hidden exposure risk for the next patient, who would have no way of knowing that the scope was previously used on someone else, or that contamination could remain inside internal channels or components.

That hidden risk has become the central allegation in Olympus scope lawsuits, which are now being investigated by individuals throughout the U.S. who have been impacted by devastating infections and outbreaks linked to reprocessed endoscopes.

Plaintiffs claim certain reusable devices were defectively designed or manufactured in ways that prevented them from being fully sterilized between patients, allowing bacteria and biological material to remain trapped inside the scopes after cleaning and posing a risk of sepsis, bloodstream infections, pneumonia, drug-resistant infections, organ failure and other serious complications.

FDA Warnings Have Long Flagged Infection Risks With Reprocessed Scopes

Federal concerns over reprocessed endoscopes first emerged more than a decade ago, after duodenoscopes were linked to outbreaks of serious infections, including antibiotic-resistant bacteria. The devices are used during ERCP procedures to diagnose and treat problems involving the bile ducts and pancreas, but their small working parts and internal channels have made them difficult to fully clean between patients.

The concern is not simply that a scope may be dirty on the outside. Regulators have warned that tissue, fluid or bacteria may remain inside hard-to-reach areas of the device after reprocessing, creating a risk that contamination may be carried into the next procedure.

Reported infections and complications linked to contaminated or improperly reprocessed scopes have included:

• Antibiotic-resistant bacterial infections
• CRE infections
• E. coli infections
• Sepsis
• Bloodstream infections
• Pneumonia
• Urinary tract infections
• Organ failure
• Death

In 2018, the FDA warned duodenoscope manufacturers, including Olympus, Fujifilm and Pentax, that they had failed to complete required postmarket surveillance studies meant to determine whether the devices could be safely reused after cleaning. The FDA ordered the studies over the severity of the potential contamination concerns, stating:

“Failure of these devices would be reasonably likely to cause infection and possibly death in patients undergoing endoscopic retrograde cholangiopancreatography procedures, which would meet the definition of “serious adverse health consequences.”
FDA Warning Letter – March 9, 2018

The FDA warning was followed later that year by a separate federal enforcement action against Olympus. Olympus Medical Systems Corporation and a former senior executive pleaded guilty to failing to file FDA-required adverse event reports involving serious infections connected to duodenoscopes, with prosecutors alleging the company continued selling the devices in the United States without providing regulators required infection-related information.

The Department of Justice said Olympus agreed to pay $80 million in fines and $5 million in criminal forfeiture.

FDA Warning Letters Put Olympus Endoscope Practices Under the Microscope

In 2022, the FDA issued two warning letters involving Olympus-related facilities in Japan, raising new questions about the company’s endoscope operations, reporting practices and manufacturing controls.

In November 2022, the FDA issued a warning letter to Aizu Olympus Co., Ltd., following an inspection of a facility that manufactured sterile and non-sterile endoscopes, as well as automated endoscope reprocessors. The agency cited problems involving federal quality system requirements, indicating that the company’s manufacturing methods, facilities or controls did not conform to required standards.

One month later, the FDA issued a separate warning letter to Olympus Medical Systems Corporation after an inspection of a facility that manufactured gastrointestinal and surgical endoscopes. The agency cited medical device reporting problems and said certain Olympus endoscopes were considered misbranded because the company failed or refused to provide required device-related information under federal reporting rules.

The warning letters directly support the product liability theory behind Olympus scope lawsuits by showing that federal concerns extended beyond isolated cleaning errors at hospitals. The FDA’s findings involved manufacturer-level failures tied to quality systems, reporting obligations, endoscope reprocessing equipment and the safety oversight of reusable devices that were designed to be cleaned and used again on multiple patients.

FDA Actions May Strengthen Olympus Scope Lawsuits

The FDA warnings, warning letters and federal enforcement actions play an important role in Olympus scope lawsuit investigations, particularly for claims alleging that infections were caused by defects in the design, manufacture, warnings or reprocessing instructions provided with reusable medical scopes.

Concerns over Olympus scope infections have already led to litigation, including a recently filed Olympus endoscope lawsuit over an ERCP infection, involving sepsis allegedly caused by a contaminated reusable scope.

Attorneys are reviewing cases involving infections, sepsis, organ failure, or other complications that occurred after a scope procedure. These claims seek compensation for medical bills, long-term health problems, lost income, and other damages. You may qualify for a surgical scope infection lawsuit if:

• You underwent an ERCP, endoscopy, colonoscopy, or bronchoscopy procedure
• The procedure involved a reusable surgical scope
• You developed a serious infection within weeks after the procedure
• The infection required hospitalization, IV antibiotics, or caused severe complications

Consultations are always free and all cases are handled on a contingency fee basis, meaning there are no upfront costs and no attorney fees unless compensation is recovered.