Olympus Scopes Lawsuit: Endoscope and Duodenoscope Infections and Injuries
Olympus Medical Systems Corporation has been hit with numerous lawsuits over alleged contamination risks associated with its reusable scopes, endoscopes and duodenoscopes. The devices have allegedly caused deadly “superbug” infections, even in cases where the devices were properly sterilized and in accordance with the manufacturer’s instructions. If you’ve been injured by a defective scope device, The Lanier Law Firm can help you file a lawsuit against Olympus and pursue the compensation you deserve.
- Legally Reviewed By:
- Kelsey Stokes
- Page Last Updated:
- May 15, 2026
Navigate This Page
- The Scope of the Problem: Potential Olympus Infection Claims in Numbers
- What Are the Risks Associated with Reusable Scopes?
- What Scope-Related Procedures Could Result in Infections and Legal Claims?
- What Types of Infections and Injuries Are Linked to Olympus Scopes?
- Who is Eligible to File a Lawsuit for Olympus Scope Infections and Injuries?
- What Types of Damages Can Plaintiffs Claim in the Olympus Lawsuit?
- The FDA’s Olympus Medical Systems Corporation Scope Alert and Investigation
- How Can The Lanier Law Firm Help Victims of Olympus Scopes?
- Contact Our Award-Winning Lawyers for Your Olympus Scopes Claim
The Scope of the Problem: Potential Olympus Infection Claims in Numbers
Our award-winning Senior Attorneys, Kelsey Stokes and David Hobbs, are leading the charge in pursuing claims against Olympus for scope infections. They shed light on the widespread nature of this issue and the many individuals who may have claims against the company, by sharing the following quick facts:
- The most common procedure in the U.S. involving reusable scopes is colonoscopies
- According to Olympus’ own estimates, there are between 17-20 million colonoscopies per year in the United States
- There are 5-10 million upper endoscopies every year in the United States
- There are 1.5 million procedures involving bronchoscopes per year in the United States
- There are 500,000 to 700,000 ERCP procedures per year in the United States
- Overall, we are looking at more than 30 million procedures per year in the U.S., with an infection rate that, depending on the procedure, could be as high as 2%
Transcript:
Kelsey Stokes:
Well, Hobbs, you’ve done some pretty significant research on potential impact across the country of these problematic reusable scopes. So, what do you think the numbers look like
David Hobbs:
Well, so first let’s talk about how many procedures there actually are. The most common procedure in the United States involving this is a colonoscopy. There are various estimates to that, but Olympus actually has its own estimates that it published late last year. And they have it between 17 to 20 million colonoscopies per year in the United States.
On top of that, you’re going to have upper endoscopies. So, those are going to be another 5 to 10 million. And then you’ll have bronchoscopes. Those will be another 1.5 million a year. And, you’ll have the ERCP procedures at roughly 500,000 to 700,000 procedures per year.
And, then when you’re looking at the number of procedures, the question then is, ok, how common are these unexpected infections where bacteria is left on a scope that then is introduced into another patient and that other patient gets sick?
Original estimates, so if you go back and look 20 years ago, 10 years ago, when they were looking at this, studies were showing the infection rates were really low. So, you were looking at 0.00001%, so a very small number of patients affected.
More recent studies have shown that that infection rate is actually significantly higher. Depending on the type of procedure, it’s going to be between 0.01% and 2% chance of infection.
Kelsey Stokes:
What does that translate to? So, you’re saying we’re looking at 30 million+ of these routine procedures, scope procedures per year, right? 30 million per year. And, so you might think 2% is a small percentage, but what does that actually equate to?
David Hobbs:
Well, if we were doing 2%, I mean, if it was 2% across the board, the numbers would be huge. But, even if we’re just assuming a sort of mixed percentage of 0.1%, we’re still looking at 30,000+ potential infections per year. And that corresponds pretty nicely with, so one of the things that we did is we looked at what’s called the FDA Mod Adverse Event Reporting. That’s where physicians, manufacturers, even patients can report information to the FDA when an adverse event like an infection happens. And, just looking from 2015, there were 10,000 reports related to these scopes, related to either infection or contamination of the scopes.
And, then when looking at those groups of reports, you might say, okay, well maybe this is the same incident being reported over and over and over again. We see that there are at least, and you can’t necessarily always tell from the data, but there are at least 2,500 separate incidents. So, these occurred at separate times, separate places, represented in that reporting. And, we know from our experience in other litigation involving medical devices and in pharmaceuticals that the FDA adverse event data is, adverse events are significantly underreported by multiple factors.
And, so the anticipation is that the numbers are going to be much, much larger than what we see in the FDA data and, again, correspond to sort of these newer estimates from studies and they may even be higher.
“Looking at 2% across the board the numbers would be huge, but even just assuming a sort of mix percentage of 0.1% we are still looking at more than 30.000 potential infections per year just in the United States” – David Hobbs, Senior Attorney at The Lanier Law Firm
What Are the Risks Associated with Reusable Scopes?
Endoscopes and similar devices are important tools commonly used by medical professionals to diagnose and treat various conditions. Different scopes are used for specific parts of the body. These flexible devices are often “reprocessed,” meaning they are disinfected and reused for future procedures.
Since 2013, the FDA has been aware of the risk of infection from reprocessed scopes, even those that had been sterilized using proper procedures. It’s possible for a defective duodenoscope to remain contaminated and spread bacteria between patients.
In January 2025, Olympus issued a voluntary recall for a particular endoscope accessory product over infection risks that led to multiple injuries and at least one death.
Transcript:
So, all of these scopes are reusable and what that means is the scope that is being used in your routine colonoscopy more than likely has been used in prior patients, potentially dozens or hundreds of prior patients.
In theory, if you reuse the scope, that scope should be sterile, it should be free of any microorganisms or any organisms at all that could hurt you, but what we have discovered is that by the design of this device, it is impossible, impossible to clean. Even when a healthcare provider, such as a hospital or a surgical center, follows the instructions for use that accompany these devices, these instructions for use that are written by the manufacturer, they follow the instructions to a T, these devices are still not clean.
So, what does that mean? That means that when you go into a procedure, there could be tissue, tissue from another patient that is then put into you during your scope procedure and it’s not just tissue. These could be microorganisms or what’s known as multi-drug resistant organisms, commonly known as superbugs. You could actually get that and within hours, days or weeks after a scope procedure, become infected, get sepsis, have significant major organ failure, and in tragic cases, you could die. That is what we have see
— Kelsey Stokes
What Scope-Related Procedures Could Result in Infections and Legal Claims?
Endoscope devices are used in hundreds of thousands of different medical procedures annually for a variety of treatment and diagnostic purposes, such as colonoscopies and endoscopies.
The following are some of the types of scope products tied to claims against Olympus, as well as some of the procedures for which they are commonly used:
- Duodenoscopes: Typically used for procedures involving the pancreas, bile ducts, liver, and other organs
- Laparoscopes: Used for minimally invasive surgeries
- Bronchoscopes: Used for procedures involving the lungs and airways
- Ureterorenoscopes: Used to treat and diagnose urinary tract problems like kidney stones
What Types of Infections and Injuries Are Linked to Olympus Scopes?
Microbial contamination of Olympus scopes that persists through sterilization can lead to potentially deadly outcomes for patients, especially when not detected quickly.
Some of the more serious effects linked to Olympus products include the following:
- “Superbug” infections with drug-resistant bacteria, such as in an outbreak tied to contaminated Olympus endoscopes at Ronald Reagan UCLA Medical Center, have contributed to at least two patient deaths.
- Bacteremia, or the presence of bacteria in the bloodstream, can lead to sepsis, a life-threatening condition in which the body’s immune system overreacts to an infection, causing it to attack itself.
- Hemorrhages, lacerations, and perforations are caused by the scope cutting or piercing internal tissue.
Hospitalized with an infection after a scope procedure? Get a free online case review.
Who is Eligible to File a Lawsuit for Olympus Scope Infections and Injuries?
If you meet one of the following conditions, you may be eligible to file an Olympus scopes lawsuit:
- You’ve had a scope procedure since 2015 that led to an infection that required hospitalization within 90 days of the procedure.
- You had a scope procedure since 2015 and were diagnosed with tuberculosis within 90 days of the procedure.
- You had a scope procedure since 2015 and were diagnosed with HIV within 90 days of the procedure.
Transcript:
So, how do you know if you potentially have a claim? Here’s what you need to be aware of. If you have had a scope procedure, so again, a colonoscopy, an upper endoscopy, bronchoscopy, that’s the lung procedure, or the procedure known as an ERCP. Any of these scope procedures, and you’ve had that since 2015.
So, if you have had a procedure and within days or weeks have had an infection that has required hospitalization, then you could have a claim.
Also very disturbing, again, the tuberculosis is a potential infection, along with HIV, even. There’s published literature that has shown that patients have been infected with HIV after undergoing these scope procedures.
Again, the infection is typically going to be one of these multi-drug-resistant organisms, or superbugs. So, if you’ve been hospitalized after having a scope procedure, within days or weeks of that scope procedure, you could have a claim.
— Kelsey Stokes
How Long Do You Have to File an Olympus Lawsuit?
The amount of time you have to file a lawsuit against Olympus depends on your state’s statute of limitations. Our experienced attorneys can help you start your claim and ensure it’s filed on time.
What Evidence Is Required to Support an Olympus Scopes Lawsuit?
Thorough medical records are vital to proving your claims in an Olympus scopes lawsuit. You must be able to establish that an Olympus scope device was used during your procedure, as well as confirm that you were diagnosed with related infections or injuries.
The right lawyer can help guide you through the process of gathering evidence and building a strong case. They can also retain experts who can provide testimony linking the impacts you’ve experienced to an Olympus product.
What Types of Damages Can Plaintiffs Claim in the Olympus Lawsuit?
Victims can pursue compensation for a variety of damages in Olympus scopes lawsuits, including the following:
- Medical bills and treatment expenses
- Lost wages and diminished future earning potential
- Pain and suffering
- Wrongful death damages, if a loved one has passed away due to the effects of a procedure using a scope
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The FDA’s Olympus Medical Systems Corporation Scope Alert and Investigation
On June 24, 2025, the FDA issued import alerts for dozens of Olympus products manufactured at a facility in Japan, citing persistent violations of quality regulations and reporting requirements. The alerts block 58 particular ureterorenoscopes, bronchoscopes, laparoscopes, and automated endoscope reprocessors from entering the United States.
In a November 2022 warning letter, the FDA detailed investigative findings that a facility that manufactures Olympus devices, run by subsidiary Aizu Olympus Co., Ltd., violated multiple “Quality System” regulations. The violations included the following:
- Failure to fully test and validate the designs of its products
- Failure to properly document and test all steps of the manufacturing process to ensure they are safe
- Failure to enact written procedures for reporting issues and adverse effects related to its medical devices
The FDA’s Center for Devices and Radiological Health explained in a January 2023 release that the warning letters issued to Olympus and its subsidiaries were part of an effort to ensure manufacturers of reprocessed endoscopes followed new guidelines instituted in response to infections caused by the re-use of these devices.
Now, the import alerts specifically mention the Aizu facility for ongoing failures to meet FDA requirements. Issues with the manufacturing process may have led to additional infections, and a lack of proper reporting may have hindered efforts to implement changes that could have protected patients.
How Can The Lanier Law Firm Help Victims of Olympus Scopes?
The Lanier Law Firm is renowned for its exceptional legal team, dedicated to obtaining settlements and verdicts for clients harmed by large corporations. Our attorneys have earned national recognition for their commitment to delivering personalized, serious legal representation. We specialize in holding powerful companies accountable, including those responsible for harmful medical devices like Olympus scopes.
Olympus, a giant in the medical device industry, generates a staggering $6.3 billion in annual revenue, with $2.4 billion coming from North America alone. With approximately 70% of the global market share in gastrointestinal endoscopes, Olympus’s defective products pose a significant risk to millions of people worldwide. The potential for harm is enormous, given the scope of their reach.
At the Lanier Law Firm, we have a proven track record of taking on corporate giants like Olympus. We understand the challenge of standing up to such powerful entities, but our history speaks for itself. Our team has successfully secured billions in compensation for victims of dangerous products, including our landmark victory in the $2.1 billion Johnson & Johnson talc case.
If you’ve been harmed by an Olympus scope, trust the Lanier Law Firm to hold them accountable and fight for the justice you deserve.
Meet Our Legal Team for the Endoscope and Duodenoscope Lawsuit
Kelsey Stokes
Senior Attorney Kelsey Stokes is a national leader in personal injury mass tort litigation, including product liability and complex commercial cases. In addition to key roles in other mass tort cases, she is currently Co-Lead Counsel for the second-largest ongoing multi-district litigation in the country and has served as lead trial counsel in three bellwether cases.
David Hobbs
Attorney David Hobbs has significant experience litigating product liability, medical malpractice, and class action cases, among other fields. He has served in leadership roles in multiple mass torts, including cases involving a variety of medical devices and other defective products.
Why Should You Choose Our Firm for Your Olympus Scope Injury Claim?
Transcript:
Kelsey Stokes:
Why should you choose Lanier? Well, I’m sure Hobbs is going to add to this, but I can tell you that we actually care about every single client who calls in. If you call in and you want us to investigate your claim, we are going to take that seriously. You are going to get personalized care and you are going to talk to an actual human being who’s going to investigate your claim.
We have had success in the billions, not only in settlements, but also in verdicts. Many of you have likely seen the recent reports of Mark Lanier and Rachel Lanier’s trial against Meta and YouTube, where Mark actually crossed Mark Zuckerberg. That was a successful result.
David Hobbs:
Yeah, so as I said, we have extensive experience, and particularly when we’re talking about this in medical device litigation, it’s a pretty specialized area, and so you have to have a lot of understanding of not only the science and the medicine of how these products are used, but you have to have, there’s an extensive legal framework that makes these very complex and very difficult to pursue if you’re not prepared.
Kelsey Stokes:
Yeah, I can’t stress enough that not every single law firm can handle a medical device case, especially of this magnitude, but we here at Lanier Law Firm are specially equipped to handle it because of the experience that both Hobbs and I have on plaintiff’s hearing committees, and as well as several attorneys, including Mark Lanier himself, who’s led numerous litigations against these major pharmaceutical and medical device manufacturers to a successful resolution.
Our clients choose the Lanier Law Firm for our unwavering commitment to their cases and the personal attention we provide. Their testimonials highlight the quality of our representation and our dedication to achieving the best possible results.
“I am so glad to have The Lanier Law Firm in my corner. They handle things quickly, communicate at every turn, and are genuinely passionate about making things right. We felt very alone, but thanks to this firm, we do not feel that way anymore. Wish I could give 10 stars.”
– Will R.
“If you need a lawyer, look no further. Lanier Law Firm will fight for you. You are not just another case for them. They make your case feel personal to them and fight for everything YOU deserve. They make you feel like family.”
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Kelsey Stokes is dedicated to mass tort litigation, product liability, and complex litigation. With extensive experience in trial and settlement negotiations, she continues to be a leader in medical device litigation recognized by Super Lawyers Rising Stars (2022).
Contact Our Award-Winning Lawyers for Your Olympus Scopes Claim
If you or a loved one has been injured after a procedure involving an Olympus scope product, our experienced legal team is ready to help you get justice. Contact The Lanier Law Firm online or call 800-723-3216 today for a free, no-risk consultation.
