Infection After a Colonoscopy, Endoscopy or ERCP: Medical Malpractice or Product Liability?

Olympus Scope Infection Product Liability Cases

Surgical scope infection cases are being pursued as product liability claims because they focus on the safety of the medical device itself, not just how the procedure was performed.

In a typical medical malpractice case, the claim involves a mistake by a doctor, nurse, hospital or other healthcare provider. This may include performing a procedure incorrectly, failing to follow accepted medical standards, delaying treatment or failing to prevent an avoidable hospital-acquired infection.

Olympus scope lawsuits involve a different issue. These cases allege that certain reusable medical scopes and accessories may have been defectively designed, manufactured or sold in a condition that made them unsafe for repeated use on multiple patients.

That distinction is important. A patient may have undergone a routine colonoscopy, endoscopy, ERCP or bronchoscopy where the procedure appeared to go as expected, but still developed a serious infection because bacteria or biological material remained trapped inside the device.

In those cases, the legal focus may shift from whether the doctor made a mistake to whether the scope itself could be safely cleaned and reused between patients.

Why Cleaning May Not Eliminate the Infection Risk

Reusable surgical scopes are designed to be used on multiple patients. During procedures like colonoscopy, endoscopy and ERCP, the scope is inserted into the body and exposed to bacteria, tissue, fluids and other biological material.

After each procedure, the device is supposed to be cleaned, disinfected and prepared for use on another patient. However, lawsuits allege that certain Olympus scopes and related accessories contain design features that may make complete cleaning difficult or impossible.

Design Features That Can Trap Bacteria

Unlike traditional surgical instruments, many reusable scopes contain complex internal structures that may be difficult to fully inspect or disinfect.

• Narrow internal channels that are difficult to flush
• Moving mechanical components that create small gaps and crevices.
• Sealed internal areas that cannot be visually inspected
• Tight spaces where biological material may collect
• Accessories or plugs that may retain contamination if not properly reprocessed

These features may allow bacteria or residue to remain inside the device after use. If the scope is later used on another patient, bacteria or other infectious material may be introduced during the next procedure.

This is why Olympus scope infection lawsuits are not limited to claims that a hospital failed to clean the device. The cases may also involve allegations that the device was not designed in a way that allowed reliable cleaning under ordinary medical conditions.

Product Liability Claims Focus on Whether the Scope Was Safe to Reuse

A product liability lawsuit asks whether a medical device was defective or unreasonably dangerous when it was placed into the stream of commerce.

In Olympus scope infection cases, the central issue is not whether the doctor performed the procedure correctly. Instead, the key questions may include:

• Was the scope designed in a way that allowed bacteria to remain trapped inside the device?
• Could the device be reliably cleaned and disinfected between patients?
• Were hospitals able to inspect the scope to confirm it was free from contamination?
• Did Olympus provide adequate warnings about the risk of infection?
• Were the cleaning and reprocessing instructions sufficient?
• Did the company continue selling or supporting devices after contamination risks became known?

These questions focus on the medical product itself. If a reusable scope cannot be reliably cleaned between uses, patients may face infection risks even when no obvious error occurred during the procedure.

FDA Warnings and Olympus Recalls Support Product Liability Concerns

Federal regulators have repeatedly examined infection risks involving reusable endoscopes, duodenoscopes and related Olympus accessories. These warnings are important because they focus on the devices themselves, including their design, reprocessing limitations and potential to remain contaminated.

FDA and Olympus Safety Actions

• Olympus Medical Systems warning letter: In December 2022, the FDA issued a warning letter to Olympus Medical Systems Corporation involving medical device reporting failures tied to gastrointestinal and surgical endoscopes. The letter stated that certain Olympus endoscopes were misbranded because the company failed or refused to provide required device-related information under federal medical device reporting rules.
• Aizu Olympus warning letter: In November 2022, the FDA issued a warning letter to Aizu Olympus Co., Ltd., after an inspection found that the company manufactured sterile and non-sterile endoscopes and automated endoscope reprocessors, and that the devices were adulterated because the company’s manufacturing methods, facilities or controls did not conform to federal quality system requirements.
• Duodenoscope postmarket surveillance failures involving Olympus: The FDA previously warned duodenoscope manufacturers, including Olympus, about failures to comply with required postmarket surveillance studies designed to assess contamination risks. Those studies were intended to help determine whether duodenoscopes could be effectively cleaned and disinfected in real-world use.
• Olympus guilty plea over adverse event reporting: In 2018, 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, while continuing to sell the devices in the United States. The Department of Justice said Olympus was fined $80 million and ordered to pay $5 million in criminal forfeiture.

These actions support cases being pursued because the FDA warnings and Olympus safety actions were not focused on whether one doctor performed a procedure incorrectly. They involved the design, cleaning limitations, quality systems, warnings and safety of reusable medical devices placed on the market. That supports the argument that scope infection cases may involve product liability issues, not just medical malpractice allegations.

Can Both the Hospital and the Scope Manufacturer Be Responsible?

Some infection cases may involve both medical negligence and product liability issues. A hospital may be responsible if staff failed to follow required cleaning steps, reused a device improperly or ignored known contamination risks.

However, Olympus and other device manufacturers may still face liability if the scope or accessory was defectively designed, inadequately tested or sold with warnings and instructions that failed to fully protect patients.

These are not always either-or cases. A legal investigation may look at both the healthcare provider’s conduct and the manufacturer’s role in placing the device on the market.

For many patients, the most important question is not simply whether someone made a cleaning mistake. The question is whether the scope was safe enough to be cleaned and reused in the first place.

Other Scope Injuries That May Involve Medical Malpractice

Not every injury after a colonoscopy, endoscopy, ERCP or bronchoscopy involves a contaminated scope. Some patients may suffer complications that raise more traditional medical malpractice concerns, depending on how the procedure was performed and how quickly the complication was recognized.

Potential malpractice claims after a scope procedure may involve injuries such as:

• Perforation, puncture or tearing of the bowel, stomach, esophagus or bile duct
• Internal bleeding after the procedure
• Pancreatitis following an ERCP
• Delayed diagnosis of a procedure-related injury
• Failure to recognize signs of infection, perforation or internal bleeding
• Emergency surgery or hospitalization after a scope procedure
• Worsening complications caused by delayed treatment

These types of claims are different from Olympus scope infection lawsuits, which focus on allegations that a reusable medical scope or accessory may have remained contaminated after reprocessing. However, a legal review may help determine whether a patient’s injuries involve medical malpractice, product liability or more than one legal claim.

Infections Linked to Colonoscopy and Endoscopic Procedures

Patients involved in these lawsuits often developed serious infections after routine procedures where they expected sterile conditions.

Common infections reported after colonoscopy, ERCP, endoscopy or bronchoscopy may include:

• Sepsis
• Bloodstream infections
• CRE infections
• E. coli infections
• Pneumonia
• Urinary tract infections
• Drug-resistant bacterial infections
• Other serious bacterial infections

Some patients may suffer severe complications, including organ failure, extended hospitalization, long-term antibiotic treatment, additional surgeries or wrongful death.

Symptoms of infection may develop within 24 to 48 hours after a procedure. However, in some cases, symptoms may not appear for several days or even weeks. This delay can make it difficult for patients to immediately connect the infection to the procedure.

Warning signs may include fever, chills, worsening abdominal pain, nausea, vomiting, weakness, confusion, difficulty breathing or symptoms of sepsis.

Allegations Raised in Olympus Scope Infection Lawsuits

Surgical scope infection lawsuits are based on allegations that manufacturers placed defective medical devices into widespread use that posed a risk of transmitting infections between patients. Common allegations include:

• Defective design: Devices were designed in ways that may prevent full sterilization between uses.
• Manufacturing defects: Problems during production may have increased the risk that bacteria could remain inside the device.
• Failure to warn: Manufacturers may not have fully disclosed the risk of infection, even when cleaning procedures were followed.
• Inadequate reprocessing instructions: Instructions provided to healthcare facilities may not have been sufficient to eliminate contamination risks.
• Continued sale despite known risks: Devices may have remained on the market even after reports of infections and contamination concerns.

These lawsuits allege that, as a result of these failures, patients were exposed to infection risks during procedures where they reasonably expected sterile equipment.

How Our Olympus Scope Lawyers Can Help

Patients usually do not know whether an infection was caused by a contaminated scope, a hospital cleaning failure or another source. That is why Olympus scope lawsuits require a detailed investigation by experienced product liability lawyers who understand how to identify the device used, evaluate the timing of the infection and determine whether the claim may involve a defective reusable medical scope.

As part of this review, our lawyers may examine:

• Procedure records identifying the type of scope used
• Hospital sterilization and reprocessing records
• Device logs and scope tracking information
• Infection culture results
• The timing between the procedure and infection symptoms
• FDA recalls, warnings or safety notices involving the device
• Whether other patients developed similar infections at the same facility
• Whether the scope design has been linked to contamination concerns

This investigation may help determine whether a case should be pursued against Olympus, another device manufacturer, the healthcare facility or more than one party.

The Olympus scope infection lawyers at Saiontz & Kirk are reviewing cases nationwide for individuals who developed serious infections after colonoscopy, endoscopy, ERCP, bronchoscopy or similar procedures. Call 1-800-522-0102 or request a free case evaluation today. There are no upfront costs, and no attorney fees unless compensation is recovered.

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