Reusable Duodenoscopes and the Push Toward Disposable Designs

A New Lawsuit Revives an Old Question About Reusable Scopes

Industry press has reported a newly filed lawsuit against Olympus alleging that a patient contracted vancomycin-resistant Enterococcus (VRE) after a procedure performed with a reusable duodenoscope, and that the infection was fatal. Other reported filings describe sepsis and death following endoscopic retrograde cholangiopancreatography (ERCP).

These are allegations. No court has determined that any manufacturer caused any of these infections, and the companies dispute the claims. But the filings raise a question that patients and families have every reason to ask: after years of revised cleaning instructions, recalls, and design changes, can a reusable duodenoscope still carry organisms from one patient to the next?

That question is what this post is about — and what people who developed a drug-resistant infection after an ERCP are often trying to understand before they talk to anyone about a claim.

Why Duodenoscopes Are Difficult to Clean

A duodenoscope is a flexible, camera-tipped instrument threaded through the mouth, stomach, and into the small intestine so a physician can reach the bile and pancreatic ducts. ERCP is the main procedure that uses it, and for many patients with gallstones blocking a duct, bile duct strictures, or pancreatic disease, it is the least invasive option available.

What makes the instrument useful also makes it hard to clean. Unlike a simple tube, a duodenoscope carries a hinged elevator mechanism at the tip that angles instruments sideways toward the duct opening. That mechanism sits in a recessed, crevice-heavy area with narrow channels behind it. Lawsuits allege that this design can retain tissue, fluid, and bacteria even when staff follow the manufacturer’s reprocessing instructions exactly.

That design theory is an allegation being litigated, not an established fact. It is, however, the central factual dispute in most of these cases.

The National Institute of Diabetes and Digestive and Kidney Diseases publishes plain-language background on ERCP and the conditions it treats, which is useful if you are trying to reconstruct why a family member had the procedure at all.

The Reported Push Toward Disposable Designs

Legal and trade coverage has reported that the FDA has urged a full transition away from fully reusable duodenoscopes toward models with disposable end caps or fully single-use designs, on the theory that removing the hardest-to-clean component removes the hardest-to-clean problem. Reporting has also described warning letters issued to duodenoscope manufacturers over postmarketing study obligations and complaint handling, and revised cleaning instructions issued for certain Fujifilm models.

We describe these as reported deliberately. If a specific regulatory action matters to your situation, the authoritative record is the agency’s own, and you can search device safety communications, recalls, and warning letters directly at FDA.gov.

The practical point for patients is simpler than the regulatory history: a transition that is still underway means reusable scopes with fixed elevator mechanisms have remained in service at some facilities. Whether a particular procedure involved one is a records question, not something a patient could have known at the time.

What Recent Olympus Regulatory News Does and Does Not Show

Two recent items circulate in coverage of this litigation and are easy to misread.

An import alert reported in mid-2025 concerned bronchoscopes, laparoscopes, ureterorenoscopes, and reprocessing equipment — not duodenoscopes. A separate correction reported in early 2026 involving certain single-use valve components was, per the company’s own reporting, issued without associated infection complaints.

Neither of those is evidence that any patient was infected. Neither establishes a defect. They are regulatory events, and a post that presents them as proof of harm would be misleading you. What matters in an individual case is that patient’s records, that patient’s organism, and that patient’s procedure — not headlines about unrelated product lines.

The Infections These Lawsuits Describe

Reported filings and outbreak investigations have involved organisms including:

• VRE (vancomycin-resistant Enterococcus)
• CRE and other carbapenem-resistant organisms
• Pseudomonas aeruginosa
• Klebsiella species
• Drug-resistant E. coli

What these share is resistance: they do not respond to the antibiotics that would ordinarily resolve a post-procedure infection. That is why a duodenoscope-associated infection can escalate to bloodstream infection, sepsis, prolonged ICU care, or death in patients who were otherwise expected to recover from a routine ERCP.

The Centers for Disease Control and Prevention maintains detailed public information on antibiotic-resistant organisms and healthcare-associated infections, including how facilities investigate clusters. Peer-reviewed literature on duodenoscope contamination and post-ERCP infection is indexed at PubMed.

Symptoms After an ERCP That Deserve Attention

Some degree of discomfort after an ERCP is expected. An infection is different. Signs that have prompted evaluation in reported cases include:

• Fever or chills in the days following the procedure
• Severe or worsening abdominal pain
• Jaundice — yellowing of the skin or eyes
• Confusion, rapid heartbeat, low blood pressure, or difficulty breathing
• Blood cultures returning a resistant organism
• Readmission or a return to the emergency department after discharge

If you are experiencing these symptoms now, seek medical care first. Sepsis is a medical emergency, and no legal question is more urgent than treatment. A claim can be evaluated later; an untreated bloodstream infection cannot wait.

These Claims Are Filed Individually — and Your State Matters

This is where endoscope infection claims differ sharply from most of the litigation covered on this site.

There is no MDL and no class action for contaminated endoscope infection claims. They are filed one at a time, in state or federal court, on behalf of an individual patient or a family. There is no consolidated proceeding, no master docket, no bellwether schedule, and no group settlement structure to opt into.

That has a consequence people often do not expect: the law of your own state is decisive in a way it is not in consolidated litigation. States differ on how long you have to file, on when that clock starts when an injury is discovered later, on what a wrongful death claim requires and who may bring it, on how medical-facility claims are handled compared to product claims, and on whether pre-suit steps apply. Two families with similar medical histories in different states can face genuinely different procedural paths.

General background on how federal civil cases proceed is available from the United States Courts. But the specific answer for your situation depends on where the procedure happened and where you live — which is a question for a lawyer looking at your facts, not a general article.

You Do Not Need to Know the Manufacturer or the Organism

This matters enough to say plainly, because it turns away people these claims exist for.

You do not need to know:

• Which company made the scope used in the procedure
• Which model it was, or whether it had a disposable cap
• The name of the organism that infected you or your family member
• How the facility cleaned its scopes
• Even, in some cases, which facility performed the procedure

Almost none of that is knowable from the patient’s side of the table. It lives in hospital records, endoscopy logs, device tracking data, culture results, and infection-control files — and obtaining and reading those records is part of what an attorney does when evaluating a case. Patients who assume they are disqualified because they cannot answer those questions are usually mistaken.

What helps is what you do know: roughly when the procedure happened, roughly where, and what happened afterward.

What Tends to Matter in an Evaluation

If you are gathering what you have, these are the pieces that typically move an evaluation forward:

• The approximate date and location of the ERCP or endoscopic procedure
• Discharge summaries, hospital bills, or an after-visit summary
• Any lab or culture results showing a resistant organism
• Records of readmission, ICU care, or extended treatment
• For a death, the death certificate and any autopsy report

Incomplete is fine. A partial set is a starting point, not a barrier. You can read more about how these cases are assessed on our endoscope infection litigation page.

Take the Next Step

If you or someone in your family developed a drug-resistant infection or sepsis after an ERCP or another procedure using a flexible endoscope, you can ask questions without committing to anything.

Because these claims are filed individually and governed by your state’s own deadlines, the timing question is worth asking sooner rather than later — and it is the kind of question that takes one conversation to answer.

Our team reviews these cases at no cost. Request a free case review to talk with someone about what happened and what your options may be.

This article is for general information only and is not legal or medical advice. No outcome is promised or implied. Every case is different, and the claims described here are allegations that have not been resolved by any court.