Case type Defective Medical Devices
Olympus Scope Infection Lawsuits
A serious infection after an endoscopic procedure can leave you facing more than a difficult recovery. You deserve answers about what happened.
If you or a loved one developed a serious bacterial infection, sepsis, or other complications after a procedure involving an Olympus endoscope, you may have questions about whether a contaminated medical device played a role.
Certain reusable scopes have been linked to infection outbreaks and safety concerns involving cleaning, disinfection, and device design14. Depending on the evidence, an affected patient or family may be able to pursue compensation.
Contact CBW Law to discuss your experience. You do not need to know the scope’s model number or have every medical record before reaching out.
Understanding Olympus Scope Infection Claims
An endoscope is a medical instrument that allows a physician to examine or treat areas inside the body. Different types of scopes are used for different procedures.
Much of the documented infection concern involves duodenoscopes, specialized instruments used during endoscopic retrograde cholangiopancreatography, or ERCP, to treat problems involving the bile and pancreatic ducts1. The history of duodenoscope infection risk does not automatically apply to every other type of endoscope.
Reusable instruments undergo “reprocessing”—cleaning and disinfection or sterilization, as applicable—between patients. The FDA has explained that a duodenoscope’s complex design can make effective reprocessing difficult. If a scope is not thoroughly cleaned, tissue or fluid from one patient can remain in it, and in rare cases that can lead to patient-to-patient transmission of infection. The agency has encouraged facilities to transition toward newer designs, including duodenoscopes with disposable components and fully disposable duodenoscopes1.
An infection following a procedure does not, by itself, establish that a scope was contaminated or that a manufacturer or healthcare provider is legally responsible. A claim requires review of the device, medical findings, timing, and other possible sources of infection.
What Has Happened With Olympus Scopes?
The history includes infection investigations, criminal enforcement, and model-specific corrective actions.
Federal investigation and criminal penalties
In December 2018, Olympus Medical Systems Corporation pleaded guilty to distributing misbranded medical devices after failing to file required adverse event reports about infections in Europe connected to its TJF-Q180V duodenoscope. The court fined the company $80 million and ordered $5 million in criminal forfeiture2.
Model-specific infection concerns
An FDA recall record for the Olympus TJF-Q190V duodenoscope describes a corrective action that began in July 2023 after reports of infections and positive cultures. The notice reminded facilities to follow the reprocessing instructions, pointed them to an updated reprocessing manual, and emphasized required inspections. The record lists the recall as open and the cause as under investigation by the firm3.
A recall may involve a correction rather than the removal of every affected device. This one was carried out through a corrective-action notice sent to the facilities that had the scope3.
These events concern particular products and circumstances. They do not establish that every Olympus scope is defective or that every infection after endoscopy came from a contaminated instrument.
Serious Infections and Complications
The Justice Department’s Olympus case identified infection events involving Pseudomonas aeruginosa and Escherichia coli2. A 2016 Senate committee staff investigation also documented duodenoscope-associated outbreaks involving antibiotic-resistant bacteria4. Infections caused by resistant germs can be difficult to treat, but the risks and outcomes vary by organism and patient5.
Sepsis is the body’s extreme response to an infection. Without prompt treatment, it can lead to tissue damage, organ failure, and death. Warning signs can include confusion, shortness of breath, fever or feeling very cold, clammy skin, a high heart rate, and extreme pain or discomfort5.
Sepsis is a medical emergency. Seek immediate medical care if you suspect it.
For a legal review, important details may include hospitalization, intensive care, additional treatment, lasting health effects, or the death of a loved one.
Could You Have an Olympus Scope Infection Claim?
A review may be appropriate if:
- You underwent an endoscopic procedure, including ERCP.
- You later received a diagnosis of a serious bacterial infection or sepsis.
- The infection required significant treatment or caused lasting harm.
- A hospital notified you of possible exposure, a contaminated instrument, or an infection investigation.
- A loved one died following an infection that may have been associated with a scope procedure.
You may not know who manufactured the scope. That information may be available in the facility’s procedure and equipment records.
There is no single timeline or checklist that establishes every claim. The relevant questions include what device was used, what organism was identified, how the infection developed, and whether the evidence connects it to the procedure.
What Evidence Can Help Explain What Happened?
An investigation may involve
- Procedure records
- The procedure date, facility, physician, and type of examination or treatment.
- Device identification
- The manufacturer, model, serial number, and scope-use records.
- Infection records
- Culture results, laboratory reports, diagnoses, and infectious-disease consultations.
- Treatment records
- Hospital admissions, medications, discharge summaries, and follow-up care.
- Facility notices
- Letters about possible exposure, recalls, or infection-control investigations.
- Financial and personal losses
- Medical bills, missed work, caregiving needs, and changes in daily life.
Cleaning, maintenance, inspection, and infection-control records may also be relevant. Some records must be requested from a healthcare facility during an investigation.
Keep copies of documents and communications you already have. You do not need to gather everything before requesting a review.
Who May Be Responsible?
Depending on the evidence and applicable law, an investigation may consider a device manufacturer, a healthcare facility, or another responsible party.
Potential issues include device design, warnings and instructions, maintenance, reprocessing, and the response to known infection concerns. Different legal standards may apply to product-liability and medical-negligence claims.
Identifying the responsible party requires evidence. Naming a manufacturer or discovering that a device was recalled does not automatically establish liability.
What Compensation May Be Available?
Depending on the facts and governing law, recoverable damages may include:
- Past and future medical expenses.
- Lost income and reduced earning capacity.
- Pain, suffering, and the effects of lasting injuries.
- Necessary care and assistance.
- Damages available to eligible family members in a wrongful-death claim.
No recovery or amount can be promised. Criminal fines and results in other cases do not determine the value of an individual claim.
How CBW Can Help
Start by telling us what happened: where you received treatment, when the infection was diagnosed, and how it affected you or your family.
CBW can review your inquiry and consider whether further investigation is appropriate. Depending on the matter, the firm may work with or refer a case to other counsel, including lawyers licensed in the relevant state.
An initial case review is free. Injury and mass tort matters are handled on a contingency basis: there is no attorney’s fee without a recovery. Case costs are separate and governed by the written agreement. See CBW’s fees, representation, and referral disclosures.
Questions
Frequently Asked Questions
Do I need to know whether an Olympus scope was used?
No. Provide the procedure date, facility, and any records you already have. Device identification may require additional records from the facility.
Can I request a review without a hospital exposure letter?
Yes. An exposure notice can be useful evidence, but its absence does not answer whether a claim exists. The medical and device records matter.
Does a recall mean I automatically qualify?
No. A recall addresses a specific product issue. A claim also requires evidence of injury, a connection to the device, and a legal basis for recovery.
What if the infection developed after a colonoscopy or another scope procedure?
Tell CBW the exact procedure if you know it. The documented duodenoscope history should not be assumed to apply to every type of endoscope, so a possible Olympus endoscope infection after another kind of procedure needs its own review of the procedure and the device.
Can I contact CBW about a loved one who died?
Yes. Whether a family member or estate can bring a claim depends on the circumstances and applicable law.
How long do I have to bring a claim?
Deadlines vary by state and claim type. Some matters also involve notice requirements or other time limits. Speak with a lawyer promptly. Contacting CBW does not stop or extend a filing deadline.
Tell Us What Happened
A serious infection can disrupt your health, work, and family life. Understanding whether a medical device contributed to it begins with the facts.
Contact CBW Law to discuss your experience and whether further legal review is appropriate.
Request a Free Case Review Call (800) 476-2416
Attorney advertising. General information only; not legal or medical advice. Contacting CBW does not create an attorney-client relationship. Results depend on the facts and applicable law. CBW is not affiliated with Olympus or the FDA. Product names belong to their respective owners.