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When a patient undergoes an endoscopic procedure, they expect the device entering their body to be clean.
Federal surveillance studies and independent clinical research have now established that reusable Olympus duodenoscopes, the type used in ERCP procedures, carry contamination rates that far exceed what regulators originally anticipated.
More than 500,000 ERCP procedures are performed annually in the United States, and the research reviewed below shows that a meaningful percentage of those procedures involved Olympus scopes that retained dangerous bacteria after hospitals completed the full manufacturer-recommended cleaning process.
The contamination problem is not primarily a matter of hospital error. It is a design problem specific to how Olympus duodenoscopes are built. These devices contain an elevator mechanism near the tip, a movable component used to guide instruments during ERCP procedures. This mechanism creates narrow crevices and moving parts that trap blood, tissue, and bacteria even after recommended high-level disinfection is completed. The FDA has formally acknowledged that infections have occurred despite healthcare facilities following Olympus reprocessing instructions exactly as written.
One FDA-reviewed study found that 87% of participants failed to correctly perform the elevator brushing task described in Olympus's own user manual, a finding that points to cleaning instructions that were not consistently executable in real clinical settings regardless of staff training or effort.
In 2015, following outbreak investigations linking contaminated Olympus duodenoscopes to patient infections at facilities including UCLA Health, the FDA ordered Olympus to conduct post-market surveillance studies measuring real-world contamination rates on patient-ready scopes.
The results were significantly worse than regulators had anticipated:
The actual contamination rate was more than 20 times higher than the FDA's baseline expectation. These findings prompted new safety communications, updated cleaning protocols, and the eventual development of disposable scope components by Olympus.
The FDA surveillance findings were not an outlier. A 2022 prospective multicenter study examined contamination across 16 U.S. clinical sites after routine reprocessing of both newer and older Olympus duodenoscope models, specifically:
Investigators concluded that contamination continued to occur in non-outbreak settings despite adherence to Olympus cleaning protocols and recommended further improvements in both device design and reprocessing procedures. A separate systematic review found that 20% of all FDA Medical Device Safety Communications issued between 2015 and 2019 involved endoscopes, reflecting how consistently Olympus and similar devices generated patient safety concerns across that period.
Outbreak investigations and surveillance studies have identified the following organisms on contaminated Olympus patient-ready duodenoscopes:
Many of these organisms resist standard antibiotics, which is why infections linked to contaminated Olympus scopes have produced outcomes including sepsis, bloodstream infections, bile duct and pancreatic infections, prolonged hospitalization, and in some cases death.
The body of research reviewed here establishes that contamination of Olympus duodenoscopes was not an unforeseeable accident. It was a documented, measurable problem that federal regulators and Olympus were studying and communicating about for years while hundreds of thousands of procedures continued annually. The UCLA Health outbreak confirmed that patient-to-patient transmission occurred even when hospitals followed Olympus's own instructions.
Olympus has since introduced disposable distal endcaps, redesigned elevator mechanisms, and fully disposable duodenoscope models in response to this accumulated evidence. Plaintiffs in active litigation argue that those design changes confirm that safer alternatives existed and that earlier action could have prevented the infections that injured and killed patients during the years those changes were delayed. In December 2018, Olympus pleaded guilty to federal charges related to failing to report infection-related adverse events and paid $85 million in criminal fines and forfeiture.
Our team has spent more than 35 years helping patients assess whether they have a viable product liability claim and connecting those who qualify with attorneys prepared to take their cases forward. If you developed a serious infection after an ERCP or endoscopic procedure involving an Olympus scope, we will review your records, evaluate your claim, and refer you to a qualified attorney. Reach out today for a free and confidential case evaluation.