What Is a Duodenoscope? The Device at the Center of the Olympus Scope Lawsuit — Explained

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Olympus Scope — Infection Claims

Hospitalized With an Infection After a Scope Procedure?

If you were told it was “just a complication,” Olympus’s federal guilty plea — and $85 million in penalties — tell a different story. In two minutes, you can know whether your case qualifies.

ACTIVE LITIGATION. 250+ patients · most recent filing: June 2026 · deadlines vary by state — some as short as one year.

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You’ll get a straight answer even if it’s “you don’t qualify.” Everything you share is confidential — even if you never hire us. No fee unless there is a recovery; costs are advanced and reimbursed only out of a recovery. If you do qualify, our Olympus scope litigation team requests the medical and hospital records — you don’t chase them.

Qualification depends on what the medical records show — the scope involved, the infection, and the timing. We’ll review them and give you a straight answer either way.

What Is a Duodenoscope and What Is It Used For?

A duodenoscope is a long, flexible tube approximately one meter in length that contains a camera, a light source, a biopsy channel, and a suction channel at its distal tip. During a procedure, the device is threaded through the patient’s mouth, down the throat, through the stomach, and into the duodenum — the first section of the small intestine. From there, physicians use the scope to visualize and treat conditions of the bile ducts, pancreas, and gallbladder during ERCP — endoscopic retrograde cholangiopancreatography.

ERCP is one of the most technically demanding endoscopic procedures performed in hospitals and ambulatory surgical centers. Between 500,000 and 650,000 ERCP procedures are performed annually in the United States, the vast majority using Olympus devices. Olympus Corporation holds approximately 70 to 80 percent of the United States duodenoscope market, making its devices the dominant platform for this procedure category.

The major components of a duodenoscope include: the insertion tube (the flexible shaft that enters the patient’s body); the control body (held by the physician, containing suction, air/water, and elevator controls); the distal tip (the end of the scope that enters the duodenum, containing the camera, light, and elevator mechanism); the elevator mechanism (the hinge-like component at the distal tip that guides instruments); the biopsy channel (through which instruments are passed during the procedure); and the suction channel (used to remove fluids from the operative field).

The elevator mechanism is the component at the center of the Olympus scope lawsuit.

What Is the Elevator Mechanism and Why Does It Cause Infections?

The elevator mechanism — also called the elevator or the bridge — is a small, hinge-like component positioned at the distal tip of the duodenoscope. During ERCP, the physician uses the elevator to guide wires, catheters, and other instruments into the bile duct opening. The elevator moves up and down through a narrow channel at the tip of the scope, controlled by a wire running the length of the insertion tube. The problem: the elevator mechanism contains microscopic crevices, joints, and a recessed channel that cannot be reached by a cleaning brush during standard manual reprocessing.

When a patient undergoes ERCP, biological material — including bacteria, blood, and tissue — accumulates in these crevices. Standard high-level disinfection leaves approximately a significant share of patient-ready duodenoscopes contaminated with gastrointestinal bacteria even when hospital staff follow manufacturer instructions exactly. (Larsen et al., 2020, cited in Bomman et al., Clinical Endoscopy, January 2022, PMC8831410.) A 2022 meta-analysis of 9,084 post-reprocessing cultures found 5 percent contamination even after enhanced cleaning protocols, with 0.8 percent high-risk organisms surviving the process.

(Bomman et al., Clinical Endoscopy, January 2022, PMC8831410.) An 8-year retrospective study at a Dutch tertiary-care hospital found that by 2022, 94.7 percent of patient-ready scopes showed measurable bacterial contamination of any type — and that all manufacturer-recommended interventions, including disposable endcap designs, new automated reprocessing machines, and staff audits, failed to produce a meaningful reduction in contamination rates.

(van der Ploeg K et al., Gut, 2024;73(4):613–621, PMID 38182137.) When the same scope is used on the next patient, the biological material trapped in the elevator mechanism can be transferred directly into the new patient’s digestive tract during the procedure. This is not a cleaning error — the device is designed in a way that makes complete decontamination of the elevator mechanism physically impossible using standard reprocessing methods.

The manufacturer, not the hospital, is responsible for providing a device that can be adequately cleaned.

How Is a Duodenoscope Different From Other Endoscopes?

Endoscopes used in medicine include colonoscopes (for the colon), gastroscopes (for the stomach), bronchoscopes (for the airways), and duodenoscopes (for the upper small intestine). The critical difference between duodenoscopes and all other endoscope types is the elevator mechanism — it exists only on duodenoscopes. Standard endoscopes — colonoscopes, gastroscopes, and bronchoscopes — have an end-viewing design with a camera at the tip and open channels running the length of the scope.

These channels can be accessed with a cleaning brush during reprocessing. Duodenoscopes have a side-viewing design: the camera looks sideways rather than forward, and the elevator mechanism creates a recessed, hinged compartment at the distal tip that standard cleaning brushes cannot access. The FDA’s February 2015 Safety Communication explicitly stated that manufacturer cleaning instructions may be inadequate to prevent the transmission of infection specifically because of this design feature.

This distinction is legally significant. The contamination outbreaks linked to Olympus duodenoscopes were not caused by hospitals cleaning the wrong type of scope incorrectly — they were caused by hospitals cleaning Olympus duodenoscopes correctly and still ending up with contaminated devices. No breach in high-level disinfection protocol was identified at Virginia Mason Medical Center (Ross et al., PMID 26092616), at UCLA Ronald Reagan Medical Center (Humphries et al., PMID 29579235), or at other affected hospitals.

The design of the device made proper cleaning impossible.

What Did Olympus Know About the Duodenoscope Design Problem?

Olympus Corporation was notified of the contamination problem years before the FDA issued any public warning. In fall 2012, a U.S. teaching hospital notified Olympus of a CRE outbreak affecting approximately 13 patients, and ECRI Institute confirmed correct reprocessing had been followed. Between November 2012 and August 2013, Virginia Mason Medical Center in Seattle reported an outbreak of MDR E. coli affecting 32 patients, including 7 who died within 31 days of the positive culture.

Olympus was notified directly but issued no public warning. (Ross et al., Gastrointest Endosc. 2015;82(3):477–83, PMID 26092616.) By 2013, the the 2013 Illinois teaching-hospital outbreak had affected 39 patients (OR=78 — JAMA 2014, PMID 25291580), and by 2014–2015 the UCLA Ronald Reagan outbreak had affected 17 patients with 2 deaths. Olympus’s first public warning in response came only after the FDA issued its Safety Communication on February 19, 2015 — more than three years after receiving the first US hospital notification.

The Senate HELP Committee investigation found that an Olympus adverse event report from December 2012 was never properly entered into the FDA’s MAUDE database. In December 2018, Olympus Medical Systems Corporation and former senior executive Hisao Yabe pleaded guilty to three counts of distributing misbranded medical devices, paying $85 million in penalties and admitting a failure to file FDA-required adverse-event reports during the period when its duodenoscopes were spreading infections across US hospitals.

Seven years later, in October 2025, Olympus issued an Urgent Field Safety Notice admitting that prior reprocessing protocols for its current-generation TJF-series duodenoscopes were insufficient and that 10X magnification tools — which hospitals had never previously been told to use — were now required to detect contamination invisible to the naked eye. The notice confirmed 2 deaths and 5 serious injuries linked to TJF-series scopes.

What Legal Claims Arise From Duodenoscope Contamination?

Patients who developed infections following procedures performed with Olympus duodenoscopes may have product liability claims against Olympus Corporation. Three primary legal theories apply in this litigation: Design defect: The elevator mechanism creates microscopic spaces that cannot be adequately decontaminated using any reprocessing method currently available. The device was designed in a way that makes patient-to-patient transmission of antibiotic-resistant bacteria an inherent risk of using the product as intended.

Failure to warn: Olympus knew of the contamination risk no later than late 2012, when it received notifications from a U.S. teaching hospital and Virginia Mason Medical Center. It failed to warn hospitals or patients of the inadequacy of its cleaning instructions for years, and its October 2025 Field Safety Notice now confirms the prior protocols were insufficient throughout the claims period. Manufacturing defect: The Olympus MAJ-891 Forceps/Irrigation Plug — an accessory used during ERCP — was subject to an FDA Class I Recall in December 2024 (Recall No. Z-0905-2025, 30,140 units).

MAUDE adverse event reports associated with this recall include 120+ reported injuries and 1 confirmed death. To potentially qualify for this litigation, a patient generally must have undergone a procedure on or after January 1, 2015, using an Olympus bronchoscope, upper GI endoscope, or colonoscope; developed a confirmed infection diagnosis; been hospitalized (inpatient) for that infection; and received IV antibiotic treatment during hospitalization, with the infection occurring within 30 days of the scope procedure.

For more information on what these claims may be worth, see our settlement value overview. Contact Marin & Murphy Law Firm today for a free case evaluation: (888) 348-2735.

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Court costs and litigation expenses are advanced by counsel and repaid from the recovery. You are not responsible for court costs or litigation expenses if there is no recovery, unless a court directs otherwise. The attorney’s fee is a percentage of the gross recovery, calculated before expenses are deducted.

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