The larger problem is contamination risk in reusable endoscopic equipment. The Food and Drug Administration (FDA) says reusable medical devices become soiled and contaminated during use and must be reprocessed correctly before they are used on another patient. With flexible scopes, that process can be unusually difficult because these devices are complex, have narrow internal channels, and may contain delicate or intricate components that are harder to clean thoroughly in real-world settings.

Why contaminated reusable scopes are dangerous

The danger is straightforward. If contamination remains inside a reusable scope or accessory after a procedure, the next patient may be exposed to bacteria or other pathogens carried over from a prior use. The resulting harm can be severe, including sepsis, bloodstream infection, pneumonia, urinary tract infection, prolonged hospitalization, invasive treatment, organ complications, and death. The FDA’s Olympus MAJ-891 safety update specifically warns that inadequate reprocessing can lead to infection, urinary tract infection, sepsis, hospitalization, IV antibiotics, and death. 

What causes the risk

The cause is not just one mistake by one technician. Public record shows several overlapping causes.

One is device complexity. The FDA’s duodenoscope safety history explains that certain reusable scopes are difficult to clean because of their intricate design, including mechanisms and internal spaces where debris and microorganisms may remain after use.

Another is damage or wear that makes a scope harder to reprocess effectively. The Centers for Disease Control and Prevention (CDC) has also identified endoscope damage, mishandling, and reprocessing deficiencies as recurring problems in investigations involving flexible endoscopes.

A third cause is accessory design and disassembly failures, where removable parts are not separated and cleaned the way the instructions require.

This goes beyond ERCP

Duodenoscopes and Endoscopic Retrograde Cholangiopancreatography (ERCP) became the most visible example because the FDA documented infections associated with reprocessed duodenoscopes. The agency later encouraged healthcare facilities to transition away from older fixed-endcap designs, urging them to move toward models with disposable components or fully disposable alternatives.

But the broader contamination problem is not confined to ERCP. The CDC’s flexible-endoscope infection-control review says gastrointestinal endoscopes and bronchoscopes have been linked to more infection outbreaks than any other semi-critical medical device, and the same underlying reprocessing risks can affect other reusable scope systems across specialties.

Flexible scopes are used across gastrointestinal care, pulmonology, and urology. Depending on the procedure, the exposure may involve upper endoscopy, colonoscopy, bronchoscopy, cystoscopy, ureteroscopy, or other scope-based interventions. That matters because a patient who develops a serious infection after one of these procedures may not realize the device itself, a reusable accessory, or the reprocessing workflow should be scrutinized.

Duodenoscopes are still the clearest warning sign

Even though this issue is broader than ERCP, duodenoscopes remain the clearest and most documented example of how dangerous reusable-scope contamination can become. The FDA says some infections associated with reprocessed duodenoscopes appeared to occur even when users reported following the manufacturer’s reprocessing instructions. That is a major point because it shifts the analysis beyond simple user error and toward device design, real-world cleaning feasibility, and whether the instructions were enough to make the product safe in practice.

Recent recalls and corrective actions show the risk did not disappear

In June 2025, the FDA posted an open Class II recall for the Olympus EVIS EXERA III Duodenovideoscope, model TJF-Q190V. The FDA said recent post-market surveillance data suggested a possible association of higher microbial contamination levels when manual cleaning was delayed beyond one hour and a presoak was performed, compared with devices where manual cleaning began within one hour after the procedure. Olympus updated its reprocessing instructions to remove the presoak step and require manual cleaning to begin within one hour after patient procedure.

That matters because it shows how contamination risk can hinge on workflow timing and reprocessing details, not just broad concepts about cleanliness. A reusable scope may appear safe on paper, yet still pose infection risk if real-world clinical conditions make the validated cleaning process hard to execute consistently. That is one reason scope contamination cases may involve product-liability issues as well as hospital-based negligence.

Scope accessories can be part of the same danger

The FDA’s update on the Olympus MAJ-891 Forceps/Irrigation Plug says patient infection can occur when reprocessing is improper or incomplete and states that Olympus reported 120 injuries and 1 death due to infection following procedures in which the accessory was used with a cystoscope. The FDA later classified the action as a Class I recall, the agency’s most serious recall category. That is powerful evidence that the risk can extend beyond duodenoscopes to reusable accessories and beyond GI procedures to urologic settings.

What patients and families should watch for

A post-procedure infection deserves closer review when it is unexpected, severe, resistant to treatment, associated with a hospital exposure notice, or follows a procedure involving reusable endoscopic equipment later tied to a recall, correction, or contamination warning.

Important records may include the procedure report, device identification, sterilization or reprocessing logs, infection-control records, culture reports, adverse-event reports, and any manufacturer notices or FDA recall materials in effect at the time.

Why these cases may involve more than a routine med-mal analysis

Some scope infection cases may involve hospital negligence. Others may involve defective design, inadequate warnings, unrealistic reprocessing instructions, servicing failures, or accessory-related contamination risks. The FDA’s own duodenoscope history shows that the agency did not treat this as a narrow, isolated human-error problem. It treated it as a persistent patient-safety issue tied in part to how reusable scopes were designed and reprocessed.

Do not assume every serious infection after a scope procedure begins and ends with the treating facility. The scope, the accessory, the cleaning protocol, the timing of reprocessing, and any recall or correction history may all matter.

Why this issue still matters now

The hard truth is that contaminated reusable scopes remain a live patient-safety issue because the underlying problem was never just one headline, one hospital, or one device generation. The FDA still maintains dedicated safety guidance on infections associated with reprocessed duodenoscopes and reprocessing of reusable medical devices more broadly. The CDC continues to warn that flexible endoscopes pose persistent infection-control challenges because of their complex design and the reality of reprocessing failures in practice.

Patients deserve to know that a severe infection after a scope procedure may have a cause worth investigating. Families deserve straight answers. And lawyers evaluating these cases should be looking beyond the procedure itself to the reusable device, its accessories, and the contamination risks built into how those products are used and cleaned.

How McEldrew Purtell can help

If you or your family member developed sepsis, a serious infection, or another severe complication after a procedure involving a reusable scope, McEldrew Purtell can investigate whether contaminated equipment, defective design, inadequate warnings, or reprocessing failures may have played a role. Contact our team for a free consultation.