Why the Duodenoscope Elevator Mechanism Drives Infection Lawsuits

Why One Small Part of the Scope Draws So Much Attention

If you or a family member developed a serious infection after an ERCP or another procedure using a flexible endoscope, you may have seen news coverage mentioning the scope’s elevator mechanism. It is a small, hinged part at the tip of a duodenoscope, and it has become the focus of much of the litigation now being brought against scope manufacturers including Olympus, Fujifilm and Pentax.

This post explains what that part does, what plaintiffs allege about it, and what the FDA has publicly said about duodenoscope-associated infections. It is educational only. Nothing here predicts an outcome in any case, and none of the allegations described below has been established as fact.

What an ERCP Is, and Why These Scopes Are Reused

ERCP stands for endoscopic retrograde cholangiopancreatography. A physician passes a flexible scope through the mouth and stomach into the upper small intestine to reach the bile and pancreatic ducts. It is used to remove gallstones, relieve blockages, place stents, and take tissue samples. The National Institute of Diabetes and Digestive and Kidney Diseases publishes patient-facing background on ERCP and related digestive procedures.

Duodenoscopes are complex reusable instruments. Rather than being discarded, they are cleaned and disinfected — a process called reprocessing — between patients, according to instructions written by the manufacturer and carried out by hospital staff.

The Design Allegation Plaintiffs Are Making

The duodenoscope’s elevator is a moveable component that raises and angles instruments so they can enter the ducts. Because it hinges, it involves crevices and a recess at the scope’s tip.

Lawsuits that have been filed allege that this design can trap tissue, fluid and bacteria in places that ordinary brushing and high-level disinfection do not reliably reach, and that manufacturers knew or should have known about that limitation and did not adequately warn hospitals and patients. Plaintiffs also allege that a safer design was feasible.

Those are allegations under active litigation, not findings. No court has determined that the elevator design caused any particular patient’s infection, and the manufacturers dispute these claims. When you read that a scope was “linked to” infections, that describes an association reported in outbreak investigations and complaint filings — not a proven mechanism in an individual case.

Reprocessing Instructions Have Been a Recurring Regulatory Theme

The FDA has issued safety communications over several years about infections associated with reprocessed duodenoscopes, and has addressed the adequacy of manufacturer cleaning instructions, postmarket surveillance obligations, and design changes such as disposable end caps.

Published reporting has also described FDA warning letters to duodenoscope manufacturers over issues including handling of infection complaints and falling behind on required postmarketing studies, as well as revised cleaning instructions issued for certain Fujifilm scopes. Reporting has likewise described FDA statements encouraging movement toward disposable-component and fully single-use duodenoscope designs. If you are researching a specific model, we would encourage you to read the FDA’s own communications rather than relying on a headline summary, because the details of what was recommended, corrected or recalled vary considerably by device.

The CDC separately maintains guidance and surveillance information on healthcare-associated infections and on carbapenem-resistant organisms, which is useful context for understanding why these infections are difficult to treat.

Two Recent Olympus Events That Are Often Misread

Because coverage of this litigation moves quickly, two items deserve care:

• A June 2025 import alert involving Olympus products covered bronchoscopes, laparoscopes, ureterorenoscopes and reprocessing equipment — not duodenoscopes. It is not evidence that anyone was infected by a duodenoscope.
• A February 2026 correction involving MAJ-1443 and MAJ-1444 valves was, per the company’s own reporting, issued without associated infection complaints. It, too, is not evidence of an infection in any patient.

A regulatory action, a correction, or a recall is a device-safety step. It is not a finding that a specific patient was harmed, and no honest evaluation of a claim treats it as one.

Infections Patients Have Reported After These Procedures

Lawsuits and outbreak reports have involved drug-resistant organisms including carbapenem-resistant Enterobacterales (CRE), Pseudomonas, E. coli, Klebsiella, and vancomycin-resistant Enterococcus (VRE). Reported outcomes have included bloodstream infection, sepsis, prolonged hospitalization, and death; recent coverage has described a newly filed Olympus lawsuit alleging a fatal VRE infection, and earlier reporting described wrongful death claims following ERCP infections.

Warning signs that follow an endoscopic procedure and warrant prompt medical attention include fever or chills, worsening abdominal pain, confusion, rapid heart rate or breathing, low blood pressure, and feeling suddenly and severely unwell. Sepsis is a medical emergency. Research literature on scope-associated outbreaks and reprocessing failures is searchable through PubMed if you want to read the underlying studies yourself.

These Claims Are Filed Individually — Which Makes Your State’s Law Decisive

This is the most important structural difference between endoscope infection claims and most other mass tort litigation.

There is no MDL and no class action for contaminated endoscope infection claims. These cases are brought as individual lawsuits in state and federal courts. If you have read about consolidated proceedings before the Judicial Panel on Multidistrict Litigation in other litigation, that framework does not apply here.

That matters in practical ways. Because each case stands on its own, the law of your state governs questions that a consolidated proceeding might otherwise smooth over: the filing deadline (statute of limitations) and when it began to run; whether and how a claim can reach a hospital or a reprocessing vendor in addition to a manufacturer; what a wrongful death claim requires and who may bring it; and whether medical-malpractice procedures, such as pre-suit notice or a certificate of merit, apply to any portion of the claim. Two families with similar infections in different states can face genuinely different deadlines and requirements.

What You Do Not Need to Know Before Asking a Question

Many people never call because they assume they lack the necessary information. You do not need to know:

• The manufacturer or model of the scope. That is documented in procedure and device-tracking records, not in patient memory.
• The organism that caused the infection. Culture and lab results identify it.
• The facility, if care spanned several. Records can be traced across providers.
• Whether the hospital’s cleaning process failed. Reprocessing logs, infection-control reports and any regulatory correspondence are obtained through the claim, not supplied by you.

What helps most is simply knowing roughly when the procedure happened, where you believe it took place, and what happened afterward. Everything else is a records question.

What Helps If You Decide to Have Records Reviewed

If you want a review, these things are useful to gather or note: the approximate date and type of the procedure; the hospital or endoscopy center; hospital discharge summaries or ICU records; any culture or lab results naming an organism; antibiotics prescribed afterward; and, in a death case, the death certificate and any autopsy report. Deadlines vary by state and can be shorter than people expect, so it is generally better to ask early than to wait until records feel complete.

Take the Next Step

If you or someone you love developed a drug-resistant infection or sepsis, or died, after an ERCP or another procedure using a reusable flexible scope, you can ask us to look at the timeline. We will tell you plainly what your state’s rules require and whether the records support a claim — including when they do not.

Learn more about our contaminated endoscope infection litigation work, or request a no-cost, no-obligation review through our free case review form.

This post is general information, not legal or medical advice, and does not create an attorney-client relationship. If you are experiencing symptoms of a serious infection, seek medical care immediately. No outcome in any case is predicted or promised.