The Other Contaminated Scopes: Ureteroscope & Cystoscope Infections

Almost everything written about contaminated medical scopes centers on the duodenoscope — the device used in ERCP to treat the bile and pancreatic ducts. That focus is understandable; the duodenoscope outbreaks were dramatic and well documented. But it leaves a real gap. The very same reprocessing problem — a complex reusable scope that can carry bacteria from one patient to the next — was flagged by the FDA in a completely different category of device: the urological endoscopes used for bladder and kidney procedures. This article walks through what the FDA found, why these scopes get contaminated, and why the legal framework built around the duodenoscope cases applies to them too.

What Are Urological Endoscopes?

Urological endoscopes are thin, flexible or rigid scopes used to look inside and treat the urinary tract. The FDA groups three main types under this heading: cystoscopes, which are passed through the urethra to examine the bladder; ureteroscopes, which travel farther up the ureter toward the kidney and are a mainstay of kidney-stone treatment; and cystourethroscopes, which combine the two. If you have ever been evaluated for blood in the urine, recurrent urinary tract infections, a bladder tumor, or a kidney stone, there is a good chance one of these devices was used on you.

These are among the most common procedures in all of medicine. They are usually quick, usually outpatient, and usually uneventful. That ordinariness is exactly why an infection afterward is so easy to dismiss as “bad luck” or a routine post-procedure urinary tract infection — when in some cases the true source was the reusable scope itself.

What Did the FDA Find?

On April 1, 2021, the FDA issued a safety communication announcing that it was investigating reports of infections associated with reprocessed urological endoscopes. The numbers were not small. Between January 1, 2017 and February 20, 2021, the agency said it had received more than 450 medical device reports describing post-procedure patient infections or other possible contamination issues tied to reprocessing these devices.

The reports included three deaths, all occurring outside the United States, and all involving infections with Pseudomonas aeruginosa — an opportunistic bacterium notorious for causing serious hospital-acquired infections. In the reports that identified a manufacturer, the FDA said the device came from either Olympus Corporation or Karl Storz. Two of the death reports were connected to a reusable forceps/irrigation plug accessory, and clinical Pseudomonas isolates matched strains found on that plug — the same accessory later pulled in the Class I recall we cover in our post on the Olympus MAJ-891 forceps/irrigation plug recall.

Crucially, the FDA said the potential causes under review were not limited to sloppy cleaning. The agency listed three areas: the reprocessing methods used, the reprocessing instructions in the device labeling, and the device design itself. Those are precisely the three pressure points at the center of the duodenoscope litigation — the question is never only “did the hospital clean it right,” but also “could this device be cleaned right by following the maker’s own instructions.”

Why Do These Scopes Get Contaminated?

The mechanism echoes the duodenoscope story. Reusable urological endoscopes have narrow internal channels, moving parts, and detachable accessories — all of which create crevices where blood, tissue, and bacteria can lodge in spaces a brush cannot reliably reach. Between patients, most were cleaned by high-level disinfection, a chemical soak that kills most organisms but does not guarantee sterility. When organic debris or a bacterial biofilm shields the microbes, high-level disinfection can leave a contaminated device that looks clean.

The FDA’s follow-up made this concrete. At the agency’s request, one manufacturer, Karl Storz, ran validation testing on a sample of flexible urological endoscopes and identified reprocessing failures following high-level disinfection. In response, the FDA moved beyond “clean more carefully” to a design-and-method fix: for certain affected scopes it recommended that facilities sterilize the devices after each use rather than rely on high-level disinfection, and advised against using an affected scope at all if an appropriate sterilization method was not available. When a regulator tells hospitals to stop disinfecting and start sterilizing, that is an acknowledgment that the prior standard of care was not enough to make the device safe.

How Is This Different From the Duodenoscope Cases — and How Is It the Same?

The devices and the procedures are different. A duodenoscope is a large, side-viewing scope with an elevator mechanism at its tip, used deep in the digestive tract; a ureteroscope or cystoscope is a slimmer instrument used in the urinary tract. The infections show up differently too. Where a contaminated duodenoscope tends to seed the biliary system and bloodstream, a contaminated urological scope tends to seed the urinary tract — producing a urinary tract infection that, in serious cases, can climb to the kidneys or spill into the bloodstream as a bloodstream infection or sepsis.

But the legal DNA is identical. Both are built on two theories that can run together. Against the manufacturer, the theory is design defect: a product is defective in design, under the risk-utility framework of the Restatement (Third) of Torts: Products Liability § 2(b), when its foreseeable risks could have been reduced by a reasonable alternative design and the failure to adopt that design left the product not reasonably safe. A scope that cannot be reliably cleaned by following its own labeled instructions is Exhibit A for that argument. Against the hospital, the theory is reprocessing negligence — a facility that failed to follow the recommended cleaning or sterilization steps, or kept using a scope after the FDA flagged it, may carry separate exposure. The same evidence — the scope model, the reprocessing logs, the culture results — drives both.

The Concern Did Not End in 2021

This is not a closed chapter. In June 2025 the FDA issued an import alert covering dozens of Olympus devices — a list that reached beyond duodenoscopes to include ureterorenoscopes, bronchoscopes, and other reprocessing-related equipment, with the agency stating it “continues to have concerns.” We break that action down in our explainer on what the June 2025 FDA import alert on Olympus scopes means for you. For a patient, the takeaway is simple: the contaminated-scope problem was never confined to one procedure. If your infection followed a urinary-tract scope rather than an ERCP, it belongs in the same conversation.

A Trial Lawyer’s Read

“Patients tend to think a urinary infection after a bladder or kidney-stone procedure is just part of the deal,” says Alex Alvarez, Managing Partner of The Alvarez Law Firm and a Board Certified Civil Trial Lawyer. “What most people never hear is that the FDA has documented hundreds of infection reports tied to these exact scopes, and that the causes it named include the device design and the cleaning instructions themselves — not just the technician. That reframes the whole question. It doesn’t win any single case on its own — you still have to prove this device infected this patient — but it means these infections deserve to be looked at, not shrugged off.”

The medical record is where a general warning becomes a specific injury. “I want to see which scope was used, whether it was cleaned by high-level disinfection or sterilized, and what organism grew in the culture,” notes Herb Borroto, M.D., J.D., the firm’s Medical-Legal Expert, who holds both a medical degree and a law degree. “If a patient grows Pseudomonas aeruginosa after a ureteroscopy, and the reprocessing records show the scope was only high-level disinfected, that pairing is exactly what the FDA was warning about. The chart is what connects a device-wide problem to one person’s harm.”

What to Do If You Were Infected After a Urological Procedure

If you or a loved one developed a serious infection — a stubborn urinary tract infection, a kidney infection, a bloodstream infection, or sepsis — in the days or weeks after a cystoscopy, ureteroscopy, or other urological scope procedure, the single most useful early step is to preserve the evidence before it disappears. That means the scope’s make and model, the hospital’s reprocessing logs for that device, and your culture and sensitivity results. Our guide on requesting and preserving hospital records after a scope infection explains exactly what to ask for, and our overview of the statute of limitations and discovery rule explains why timing matters so much.

From there, a prompt, no-obligation review with a lawyer who handles these cases can tell you whether your facts fit the pattern and whether a filing deadline may be approaching. We represent patients nationwide.

Free case review. No Fees Unless We Recover Money for You.

Frequently Asked Questions

Are ureteroscope and cystoscope infections part of the same scope-infection problem as duodenoscopes?

Yes — they are a separate branch of the same underlying problem. Duodenoscopes used in ERCP get the most attention, but in April 2021 the FDA issued a safety communication about infections tied to reprocessed urological endoscopes, a category that includes cystoscopes, ureteroscopes, and cystourethroscopes used to examine and treat the bladder, ureters, and kidneys. The mechanism is the same: complex, hard-to-clean reusable scopes that can carry bacteria from one patient to the next even after the recommended cleaning steps are followed.

What is a cystoscopy or ureteroscopy, and why would it cause an infection?

A cystoscopy uses a thin scope passed through the urethra to look inside the bladder; a ureteroscopy passes a scope farther up the ureter toward the kidney, often to find or break up a kidney stone. These are common, usually routine procedures. An infection can occur when the reusable scope was not fully sterilized between patients and carries bacteria into the urinary tract. Because the urinary tract can seed bacteria into the bloodstream, a contaminated scope can lead to a urinary tract infection, and in serious cases to bloodstream infection or sepsis.

What did the FDA say about reprocessed urological endoscopes?

In its April 1, 2021 safety communication, the FDA reported that between January 1, 2017 and February 20, 2021 it had received more than 450 medical device reports describing post-procedure infections or possible contamination associated with reprocessed urological endoscopes. Three deaths were reported outside the United States, all involving Pseudomonas aeruginosa infections. In reports that named a manufacturer, either Olympus Corporation or Karl Storz was identified. The FDA said the causes under review included reprocessing methods, the cleaning instructions in the device labeling, and device design, and it later recommended sterilization rather than high-level disinfection for certain affected scopes.

I developed a serious infection after a kidney stone or bladder procedure — do I have a case?

You may. Whether a claim exists depends on your specific facts — the scope make and model used, the organism cultured, how the device was cleaned and documented, and your state’s filing deadline. The most useful early step is to preserve the evidence: the scope’s make and model, its reprocessing records, and your culture results, before routine record-retention schedules erase them. A prompt, no-obligation review with a lawyer who handles these cases can tell you whether your facts fit the pattern. No outcome is promised or guaranteed, and past results do not predict future ones.

Sources

• U.S. Food & Drug Administration — “The FDA is Investigating Reports of Infections Associated with Reprocessed Urological Endoscopes” (Safety Communication, April 1, 2021; more than 450 medical device reports Jan. 1, 2017–Feb. 20, 2021; three deaths outside the U.S. involving Pseudomonas aeruginosa; manufacturers Olympus or Karl Storz; causes under review: reprocessing methods, labeling, device design). fda.gov
• U.S. Food & Drug Administration — “UPDATE: Change in Reprocessing Methods with Certain Karl Storz Urological Endoscopes — Letter to Health Care Providers” (validation testing identified reprocessing failures after high-level disinfection; recommendation to sterilize affected scopes after each use). fda.gov
• U.S. Food & Drug Administration — “Reprocessing of Reusable Medical Devices” (high-level disinfection vs. sterilization; reprocessing standards for reusable endoscopes). fda.gov
• American Law Institute — Restatement (Third) of Torts: Products Liability § 2(b) (reasonable alternative design / risk-utility test). ali.org

This article is for general informational purposes only and is not legal advice. It summarizes public regulatory findings and medical background about a category of medical devices; it does not describe the outcome of any client’s case. Nothing here creates an attorney-client relationship, and no result is promised or implied. Past results do not guarantee future outcomes. Deadlines and legal standards vary by state and by the facts of each case. If you believe you may have a claim, consult a licensed attorney promptly.