Colonoscopy Infection Lawsuit Filed Over Contaminated Olympus Scope

Inability to properly clean reusable endoscopes between procedures has been linked to infectious disease outbreaks, FDA warnings and concerns about hidden contamination for more than a decade.

A Chicago woman has filed a product liability lawsuit against Olympus Corporation, blaming design problems with the company’s endoscopic devices for an infection that led to permanent injuries.

The complaint (PDF) was brought by Denise Hopkins in the U.S. District Court for the Northern District of Illinois on July 9, naming Olympus and several of its subsidiaries as defendants.

Hopkins alleges that the colonoscope used during a medical procedure she underwent led to a Clostridioides difficile (C. diff) infection due to a defective design that makes cleaning infectious material between procedures difficult.

Olympus Endoscope Problems

Endoscopes and related medical scopes, such as duodenoscopes and colonoscopes are used during procedures including ERCP, colonoscopy, upper endoscopy and bronchoscopy. The devices contain small cameras, lights, long narrow channels and moving parts, allowing doctors to examine internal organs, make medical diagnoses and perform certain procedures without the need for surgery.

Overall, estimates indicate there are 22 million gastrointestinal endoscopic procedures performed in the U.S. every year. That includes about 15 to 19 million colonoscopies, a significant portion of the world’s 50 million annual colonoscopy procedures.

Because the devices are often used on multiple patients, they must be thoroughly sterilized between each procedure. If not cleaned properly, bacteria, biofilm, tissue and other debris may remain trapped inside the scopes, especially in narrow channels or damaged areas that are difficult to inspect, allowing infections to pass from one patient to another.

Due to these problems, Olympus colonoscopy infection lawsuits are being filed in courts nationwide, each alleging that the company’s endoscope devices are poorly designed, putting consumers at risk of serious and potentially life-threatening infections.

Colonoscopy Infection Allegations

According to the complaint, Hopkins underwent a colonoscopy with an Olympus CF-HQ190L colonoscope on August 8, 2024, and began experiencing loose stools after the procedure. By late August, she allegedly developed liquid diarrhea, severe abdominal cramping and bright red blood in her stool.

Hopkins went to the emergency room on August 31 and returned on September 3 after being referred by her primary care physician. She was hospitalized for 10 days and diagnosed with C. diff for the first time.

Doctors initially treated her with vancomycin before switching her to fidaxomicin. However, she was diagnosed with C. diff again in October 2024 and required additional medication.

C. diff is a bacterial infection that can cause severe diarrhea and inflammation of the colon. Although it frequently affects patients following healthcare exposure or antibiotic use, Hopkins alleges her infection was caused by contamination remaining inside the reusable Olympus colonoscope.

She claims she continues to suffer recurring infections, chronic fatigue, medical expenses and fear of undergoing future endoscopic procedures.

“Defendants’ Endoscope Device is defective because, among other defects, medical providers were not able to safely and effectively sanitize and clean the Endoscope Device even if the providers strictly complied with Defendants’ reprocessing instructions contained in the Product Labeling.”

–  Denise Hopkins v. Olympus Corporation et al.

The lawsuit alleges Olympus failed to develop and validate a reprocessing protocol capable of reliably cleaning its colonoscopes. The lawsuit also alleges repeated use and reprocessing may cause internal components to crack or deteriorate, including lenses, channel linings and adhesives. Scratches, channel shredding and other damage may create hidden areas where bacteria and biofilm can accumulate beyond the reach of chemical disinfectants.

She cites an FDA-ordered human-factors study in which healthcare workers failed to successfully complete numerous critical reprocessing steps. The complaint alleges the study ultimately found Olympus’s instructions were not sufficient to consistently ensure compliance with important cleaning, disinfection, rinsing and storage procedures. A separate postmarket study allegedly found no contamination in only 34.8% of sampled endoscopes.

Hopkins presents claims of defective design, failure to warn, manufacturing defect, negligence, negligence per se, gross negligence, breach of express and implied warranties, negligent and intentional infliction of emotional distress, negligent misrepresentation, fraud and fraudulent concealment. She seeks compensatory and punitive damages.

Olympus Endoscope Lawsuits

Endoscopes by Olympus and other manufacturers, like Fujifilm, have been plagued by sterilization problems for years. In 2014 and 2015, duodenoscopes used during ERCP procedures were linked to an outbreak of an antibiotic-resistant bacterial infection known as carbapenem-resistant enterobacterales (CRE).

Data also linked those infections to a failure to properly clean the devices. They contained a movable “elevator” at the tip, which contained cracks and crevices where pathogens, blood and tissue persisted even after the manufacturers’ sterilization and cleaning instructions were followed.

In 2018, the U.S. Food and Drug Administration (FDA) issued a duodenoscope warning, indicating manufacturers had failed to conduct the proper post-marketing surveillance to ensure the devices were as safe in real-world use as they had been during clinical trials.

During the next year, the industry began to move toward disposable elevator tips. However, the latest lawsuits suggest the problems have not yet been resolved.

Contaminated endoscope attorneys are currently investigating potential lawsuits for those who developed infections after undergoing a medical procedure with a reusable surgical scope, including:

To determine whether you or a family member may qualify for a surgical scope product liability lawsuit, submit your information for a free case evaluation. An attorney can review your situation, explain your legal rights and determine whether you may be eligible to pursue compensation.

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