Olympus Duodenoscopes Are Back in the News

That notice did not come out of nowhere. We have seen this pattern before. And patients keep getting hurt.

If you or someone you love developed a serious infection after an ERCP (e.g. sepsis, a CRE or other drug-resistant bloodstream infection, cholangitis, pneumonia, organ failure, or death), the scope itself may be what caused it. Not just the hospital. Not just bad luck. The device.

A Case We Handled

We have handled this case before.  Several years ago our firm represented the family of a 76-year-old Allegheny County woman who entered a Pittsburgh hospital with painless jaundice. She had been living independently, and while she had a history of heart disease, she was not acutely ill when she walked in. Doctors performed an ERCP using an Olympus TJF-Q180V duodenoscope. Within about 48 hours she was tachycardic, diaphoretic, passing bloody stool, and hyperventilating in the ICU. Her blood cultures grew carbapenem-resistant Klebsiella pneumoniae, a bacterium that shrugs off most of the antibiotics we have. She never recovered. She died a few months later.

The reason the infection landed in her bloodstream was not, as it turned out, a mystery. When we pulled the hospital’s “look-back” records, the log of every patient the same scope had been used on in the weeks before her procedure, we found that the scope had been used on a prior patient with documented KPC CRE bacteremia. Despite reprocessing, the organism had remained on the device. Our infectious disease expert concluded to a reasonable degree of medical certainty that the contaminated duodenoscope was a substantial factor in causing her infection and her death.

The scope’s design was the other half of the story. The TJF-Q180V had a sealed elevator wire channel with a small O-ring at its base. Behind that O-ring sat a recess that was, for practical purposes, impossible to clean. Biological material could wick past the seal during use and then sit there. Researchers at Erasmus University Medical Center in the Netherlands had demonstrated this in 2012, after an outbreak of VIM-2-producing Pseudomonas aeruginosa sickened 22 of their ERCP patients. That report was published. Olympus knew about it.

Olympus recalled the TJF-Q180V in January of 2016. And that, in theory, should have been the end of it.

What the FDA’s Own Data Actually Showed

It was not the end of it.

After the wave of outbreaks in 2015, the FDA ordered Olympus, Pentax, and Fujifilm to run post-market surveillance studies — go out into real hospitals, sample real reprocessed scopes, and culture them. The preliminary numbers showed about 3% of properly collected samples growing “high-concern” organisms like E. coli, Klebsiella, Pseudomonas, or Staph aureus. Bad. Subsequent interim results pushed that up to 5.4% for high-concern organisms. Worse.

An independent 2020 meta-analysis of the worldwide literature estimated the pooled contamination rate of patient-ready reprocessed duodenoscopes at roughly 15%. A Dutch surveillance program showed 22% of scopes contaminated at levels sufficient to quarantine the device. Somewhere in this range is the real number. None of them are small.

Eventually the FDA stopped calling the infection risk “relatively low.” It pushed manufacturers toward disposable-component designs. Olympus and Pentax pulled their older fixed-endcap scopes off the market. Fujifilm withdrew its fixed-endcap device before its surveillance study was even complete.

For context: duodenoscopes are used in more than half a million ERCP procedures a year in the United States, and since 2012 there have been more than 25 reported outbreaks of multidrug-resistant organisms worldwide traced back to patient cross-contamination through these devices. This is not a rare-device problem. It is one of the most common “lifesaving” procedures in American hospitals, performed with a device the manufacturer has repeatedly struggled to make reliably cleanable.

The New Scope Was Supposed to Fix This

In January 2020, Olympus announced FDA clearance of the TJF-Q190V — the successor to the Q180V. The marketing around the Q190V was exactly what you would expect after the prior generation blew up in court and in the press. Olympus pointed to a sterile, disposable distal endcap, a proprietary flushing adapter for the elevator mechanism, a “sealed” elevator wire channel port that supposedly did not require separate cleaning, and a water-resistant scope connector. Human factors studies. Improved visualization. Reduced contamination.

The deal, again, was this: if you follow our cleaning instructions, the scope is safe.

By 2025 that deal was in trouble.

2025: Four Separate Warning Signs in One Calendar Year

If you skim nothing else, skim this part. These are the specific things Olympus and the FDA put on the record in 2025, in order.

January 16, 2025 — Recall of the distal cover. Olympus initiated a Class 2 recall of the MAJ-2315 Single Use Distal Cover, the disposable cap used with the TJF-Q190V. Reason for the recall: the cover could unexpectedly detach from the duodenoscope during a procedure. When that happens inside a patient you get mucosal injury, tissue damage, bleeding, perforation, or obstruction. None of that is something a patient consented to.

May 2025 — Olympus rewrites the cleaning manual. Olympus sent customers a letter announcing it was revising Section 5.9 of the reprocessing manual for the TJF-Q190V, Q290V, and Q170V. The prior version of the manual had told hospitals, in validated instructions, that if manual cleaning could not start within an hour of a procedure, staff could do an extended detergent presoak and delay cleaning for up to 24 hours. Olympus removed that option entirely. It also deleted the “presoak the endoscope” step. The rationale, in Olympus’s own words, was post-market surveillance data suggesting a possible association of higher microbial contamination levels when cleaning was delayed beyond an hour and a presoak was performed.

Read that again. The cleaning instructions hospitals had been relying on — and that Olympus had told them were validated — were actually producing more contamination in real-world use, not less.

June 24, 2025 — FDA Import Alert. The FDA issued an Import Alert covering dozens of Olympus device models manufactured in Japan. Import alerts let the agency detain products at the border without physical examination. They are not routine. They get issued when the FDA has lost confidence in a manufacturer’s quality system.

October 17, 2025 — Urgent Field Safety Notice. This is the one that should make patients pay attention. Olympus sent a worldwide Urgent Field Safety Notice for the TJF-Q190V, Q290V, and Q170V duodenoscopes. The company admitted the notice was prompted by its ongoing assessment “to address positive cultures and infections.” It confirmed that from 2024 to the date of the notice, it had received two reports of death and five reports of serious injury connected to infections or positive cultures involving these scopes. And it rolled out a new requirement: hospitals now have to visually inspect the distal tip under 10x magnification, because, in Olympus’s own words, naked-eye inspection cannot reliably detect the irregularities and damage that can trap bacteria.

Think about what that magnification requirement actually means. For years, Olympus’s defense in these cases — and the hospital’s defense, and the insurer’s defense — has been that the device is fine if you follow the instructions. If the standard of care now requires 10x magnification to verify a scope is clean, what were hospitals using before October 17, 2025? The answer is: their eyes. Which Olympus now concedes is not enough.

Why These Cases Are Real, and Why They Are Hard

Plaintiff’s lawyers get a lot of calls after news like this breaks. Not every call becomes a case. These matters are difficult to prove, and the law firms hired by the defendants are sophisticate and formidable.

On the plaintiff side there are usually four potential theories, and the right case has more than one of them working at the same time:

A design defect claim against Olympus — the device’s elevator mechanism traps organic material in places hospital staff cannot physically reach, no matter how careful they are.

A failure-to-warn claim against Olympus — particularly where the company knew about contamination clusters, or issued safer instructions in Europe before making them available to U.S. hospitals, which happened with the prior generation scope and which the October 2025 notice suggests may be happening again.

A negligent reprocessing instructions claim — the instructions themselves have been demonstrably wrong. Olympus has now rewritten them twice in the span of a decade.

A medical negligence claim against the hospital — for failing to train, supervise, and discipline its reprocessing staff, for tolerating shortcuts, for ignoring culture data from look-back investigations, or for using the scope on a new patient after it had been used on a known CRE-positive patient.

Building the case requires pulling the procedure date, the facility, the exact scope model and serial number, the device-tracking logs, the operative note, the infection-control records, all microbiology data (ideally genetic typing of the organism), the patient’s full hospitalization and infectious disease workup, and — critically — the hospital’s look-back log showing every patient that scope was used on in the weeks before the infection appeared. That last document is where these cases are won or lost.

Causation in a medically fragile patient is its own battle. ERCP patients tend to be older and sicker than average. Many have cancer, heart failure, or both. The defense will push hard on preexisting life expectancy. Under Pennsylvania law that argument does not defeat the case. It affects damages, not liability, and in a wrongful death or survival action against a hospital the analysis runs through the Hamil v. Bashline increased-risk-of-harm framework — a plaintiff-friendlier standard than strict but-for causation. We have litigated that framework repeatedly.

What To Do If This Sounds Familiar

If you, or a parent, or a spouse, underwent an ERCP, a bronchoscopy, a ureteroscopy, or another flexible-endoscope procedure — especially in 2024 or 2025 — and afterward developed a serious infection, sepsis, or died, some of the evidence in your case is perishable. Device-tracking logs get overwritten. Look-back investigations get shelved. Cultures get discarded. Statutes of limitations run.

We are actively reviewing these cases. There is no charge for the consultation and no obligation. We work entirely on contingency, which means our fee comes out of a recovery or there is no fee at all.