Duodenoscope Infections: A Patient Guide

A plain-language explainer on duodenoscopes, the “superbug” infections that have been linked to them, and what patients who have had an ERCP procedure may want to know. This page is for general information only — it is not legal or medical advice.

What is a duodenoscope?

A duodenoscope is a flexible, lighted tube that physicians thread through the mouth, stomach, and into the first part of the small intestine. It is the essential instrument for a procedure called ERCP (endoscopic retrograde cholangiopancreatography), which doctors use to diagnose and treat problems of the bile ducts, pancreas, and gallbladder — things like gallstones, blockages, and certain cancers. Roughly half a million ERCP procedures are performed in the United States each year, and for most patients the procedure is both effective and uneventful.

Why these scopes are hard to clean

Unlike most surgical instruments, duodenoscopes are reused from patient to patient. Between uses they go through a rigorous disinfection process called reprocessing. The difficulty is a small hinged mechanism at the tip of the scope — the elevator — that lets the physician steer tiny tools into the bile duct. The elevator’s moving parts contain microscopic crevices that brushes and disinfectant cannot reliably reach. Studies have found that a meaningful share of patient-ready duodenoscopes remain contaminated with gastrointestinal bacteria even when hospital staff follow the manufacturer’s cleaning instructions exactly.

The infections that have been linked to duodenoscopes

When bacteria survive reprocessing, they can be carried from one patient into the next patient’s bile ducts or bloodstream. The organisms most often documented in scope-related outbreaks are antibiotic-resistant — which is why news coverage has used the word “superbug.” They include CRE (carbapenem-resistant Enterobacteriaceae), which the CDC reports can be fatal in roughly 40–50% of bloodstream infections, along with NDM-producing E. coli and other multidrug-resistant organisms. Documented hospital outbreaks have included Virginia Mason Medical Center in Seattle (32 patients infected), UCLA Ronald Reagan Medical Center and Cedars-Sinai in Los Angeles, and an Illinois teaching hospital where 39 patients were infected. A 2016 U.S. Senate committee investigation estimated that at least 250 patients worldwide contracted potentially deadly infections linked to contaminated duodenoscopes.

What regulators and the manufacturer have done

This issue has a long public record, and it is still developing:

• February 2015 — The FDA issued a Safety Communication warning that duodenoscope cleaning instructions may not be sufficient to prevent infection transmission.
• 2016 — A Senate investigation criticized the largest scope manufacturer, Olympus, for delays in reporting infections; Olympus recalled and redesigned its most widely used model.
• 2018 — Olympus Medical Systems pleaded guilty to federal charges of distributing misbranded devices and failing to file required adverse-event reports, paying $85 million in penalties.
• December 2024 — The FDA announced a Class I recall (its most serious category) of an Olympus scope accessory, covering more than 30,000 units.
• June 2025 — An FDA import alert blocked dozens of Olympus device models from entering the U.S.
• October 2025 — Olympus issued an Urgent Field Safety Notice stating that prior reprocessing protocols for its current-generation TJF-series duodenoscopes were insufficient, and disclosing patient deaths and serious injuries.

Symptoms patients have reported after ERCP

Post-ERCP infections typically appear within days to a few weeks of the procedure. Medical sources describe symptoms such as fever and chills, abdominal pain, nausea, dark urine or jaundice (signs of bile duct involvement), and in serious cases sepsis — a rapid, body-wide response to infection that is a medical emergency. Anyone who experiences these symptoms after an ERCP should contact their doctor promptly and mention that the procedure involved a duodenoscope; that detail helps clinicians choose the right cultures and antibiotics, because resistant organisms do not respond to standard first-line drugs.

Questions patients can ask their care team

Patients scheduled for an ERCP, or those who have had one recently, sometimes ask: Which scope model will be (or was) used? How is it reprocessed, and has the facility adopted the newer cleaning protocols or single-use scope designs? Has the hospital had any scope-related infection events? These are reasonable patient-safety questions, and hospitals’ infection-control teams are accustomed to answering them.

The legal landscape, briefly

As a factual matter, lawsuits over duodenoscope-related infections have been filed in federal and state courts for a decade — including a $6.6 million jury verdict in a Seattle wrongful-death case in 2017 — and new filings resumed in 2026 following the recent recalls and safety notices. There is currently no consolidated multidistrict litigation; cases proceed individually. Patients who believe they were affected sometimes choose to speak with an attorney in their state; others direct questions to their hospital’s patient-safety office. Both are personal decisions, and time limits for legal claims vary by state.

Where to learn more

Primary sources on this topic include the FDA’s duodenoscope safety communications (fda.gov), the CDC’s pages on CRE (cdc.gov), and the 2016 Senate HELP Committee report on duodenoscope-linked outbreaks. For questions about your own health after an ERCP, your physician remains the right first call.

About this page. This guide is published by Marin & Murphy Law Firm as a public-information resource. It is not legal advice, not medical advice, and not a solicitation; reading it does not create an attorney-client relationship. Facts above are drawn from FDA communications, CDC data, the 2016 Senate HELP Committee report, and public court records.

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