Olympus Scope Complications: ERCP, Colonoscopy and Endoscopy Risks

Researchers gather data on Olympus scope complications from clinical trials, studies and reports to the FDA. The research is split between complications that can happen with any scope — such as pancreatitis, bleeding and a tear called a perforation — as well as infection risks specific to scope design and poor cleaning.

Scientists use large-scale patient studies to learn what complications occur and estimate how often they happen. Outbreak investigations examine how a scope may cause infections.

For example, the FDA received reports of infections linked to Olympus scopes. The agency conducted testing on these scopes after the reprocessing, cleaning and disinfection or sterilization process required before doctors reuse the scopes. The FDA later determined that the design of Olympus scopes could cause bacteria to remain even after cleaning.

In general, endoscopic retrograde cholangiopancreatography (ERCP) has the highest complication rate of routine endoscopic procedures. Complications may include pancreatitis, bleeding, perforation and infection of the bile ducts, also called cholangitis. ERCP allows doctors to treat blockages and other problems in the bile and pancreatic ducts.

Duodenoscopes are special scopes used in ERCP, and the devices made by Olympus were at the center of the FDA infection outbreak warnings.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) estimates that complications occur in about 5% to 10% of ERCP procedures and often require hospital treatment.

Post-ERCP Pancreatitis, Bleeding and Perforation Rates

Pancreatitis, bleeding and perforation rates after ERCP vary depending on the study. The highest rates are for pancreatitis, while perforation had the lowest rates.

A 2007 review in the American Journal of Gastroenterology combined 21 prospective surveys involving 16,855 patients and found pancreatitis after 3.47% of procedures. The review reported bleeding in 1.34% of procedures and perforation in 0.60%.

A newer review published in Gastroenterology in 2025 included 380 studies and found post-ERCP pancreatitis in 4.6% of patients overall.

Among patients having their first ERCP, the pooled pancreatitis rate was 6.5%. The review also reported bleeding in 1.5%, cholangitis in 2.5% and perforation in 0.5%.

A person’s general health may increase their risk for ERCP complications. For example, people with end-stage renal disease and liver cirrhosis could be at a higher risk. These estimates cover the procedure rather than a particular Olympus scope model, and individual risk requires a discussion with your treating physician.

Duodenoscope Infection Studies

Duodenoscope infection evidence includes hospital outbreaks, bacterial testing and FDA surveillance studies. The FDA found that some infections occurred even after following the manufacturer’s cleaning, disinfection or sterilization instructions.

Infections linked to contaminated scopes include CRE, VRE, Pseudomonas, E. coli, C. diff, Mycobacterium and sepsis.

A 2016 U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) minority staff report identified at least 25 incidents of antibiotic-resistant infection linked to closed-channel duodenoscopes between 2012 and spring 2015, involving at least 250 patients worldwide.

At the time, Olympus manufactured about 85% of the duodenoscopes in the U.S. The committee found that the company had study data from two labs and knew its scope design could harbor and spread bacteria in 2013. But it didn’t inform the FDA, hospitals, physicians or patients until 2015.

Serious colonoscopy complication rates are generally low, and bleeding and perforation are among the best-studied risks. A 2023 clinical review in BMJ Open Gastroenterology cited complication rates of 2.8 per 1,000 (about 0.28%) screening colonoscopies and 5 per 1,000 (about 0.5%) examinations in people with symptoms of a potential health issue.

Perforation and Bleeding Rates

A 2016 meta-analysis in the American Journal of Gastroenterology included 21 population-based studies of complications within 30 days of colonoscopy. It found approximately 0.5 perforations and 2.6 bleeding events per 1,000 procedures.

When polyps, abnormal growths of tissue that project outward from a mucous membrane, were removed, the pooled estimates were 0.8 perforations and 9.8 bleeding events per 1,000 procedures. NIDDK likewise notes that bleeding and perforation occur more often in older patients and people who have polyps removed.

The 2023 review in BMJ Open Gastroenterology describes several possible causes of perforation, including force from the device, pressure from introduced gas and injury during polyp removal.

Infection Rates After Colonoscopy

Overall, infection rates after colonoscopy aren’t common, occurring in about 1 in 1,000 procedures.

A Johns Hopkins-led study published in Gut in 2018 analyzed 2014 insurance claims from ambulatory surgery centers in six U.S. states. The dataset included 462,068 screening colonoscopies and 914,140 nonscreening colonoscopies.

Within seven days, infection-related emergency visits or unplanned admissions occurred at rates of 1.1 per 1,000 screening procedures and 1.6 per 1,000 nonscreening procedures.

A separate 2016 pilot study sampled five colonoscopes, five gastroscopes and five bronchoscopes after full reprocessing and recovered viable microbes from three of the colonoscopes. This small contamination study did not measure how often patients became infected.

A 2017 study tested colonoscopes and gastroscopes three times over seven months. After testing ended, 12 of 20 devices had microbial growth, and more intensive reprocessing didn’t always eliminate contamination. The study results point to potential cleaning concerns that could increase infection risk, not necessarily infection rates after a colonoscopy.

Upper endoscopy complications include bleeding, perforation and reactions to sedation. Infection is another concern studied after the procedure. NIDDK describes the overall risks as low and serious problems such as perforation as rare.

Also called EGD, upper endoscopy examines the esophagus, stomach and first part of the small intestine. Unlike ERCP, a routine EGD does not involve the specialized procedure used to enter and treat the bile and pancreatic ducts.

A 2022 review by Waddingham and colleagues reported that prospective multicenter studies placed perforation after diagnostic upper endoscopy between 1 in 2,500 and 1 in 11,000 procedures. Those estimates pertain to diagnostic examinations and should not be applied to more complex treatments performed via endoscopy.

The review identified narrowing of the esophagus and some other preexisting structural problems as risk factors for perforation. It also emphasized that recognizing a complication quickly and arranging appropriate care can help limit further harm.

Infection Rates After Upper Endoscopy

In the Johns Hopkins study, unplanned infection-related hospital visits within seven days occurred in 3 per 1,000 upper endoscopies. That was higher than the screening-colonoscopy estimate in the same study, but the comparison does not show that one scope brand caused more infections.

A 2015 study in the American Journal of Infection Control followed 15 colonoscopes and gastroscopes across 60 sampling encounters and detected viable microbes after high-level disinfection. The researchers observed that microbes remained on the scopes even when staff followed all guidelines and cleaning steps.

In 2009, the VA reported some veterans tested positive for hepatitis B, hepatitis C and HIV after some endoscopes were improperly cleaned. The VA explicitly said those results did not establish a relationship between the infections and the procedures.

Bronchoscopy complications can include bleeding, a collapsed lung called pneumothorax, infection and low blood oxygen.

Bronchoscopy allows a doctor to examine the airways and take samples of mucus or tissue. Fever or minor bleeding are small risks, while a collapsed lung is a rare but serious complication.

Bronchoscope Contamination Reports

The FDA’s 2021 update cited 109 reports of infection or contamination involving reusable flexible bronchoscopes from January 2010 through June 2015. From July 2015 through January 2021, there were 867 more. The FDA’s June 2025 Olympus import-alert list included 24 bronchoscope models.

A 1997 investigation used DNA fingerprinting and procedure records to identify a contaminated bronchoscope as the most likely source of tuberculosis transmission between two patients.

Olympus Corporation duodenoscopes and endoscopes have been linked to multiple major outbreaks of deadly, antibiotic-resistant “superbugs,” such as Carbapenem-resistant Enterobacteriaceae (CRE). Symptoms of CRE include fever, chills and severe sepsis.

Investigations at Virginia Mason and UCLA illustrate how shared scope exposures and laboratory evidence helped identify the source of the outbreaks.

The Senate’s 2016 report described an outbreak contained in early 2014 after at least 32 Virginia Mason patients acquired antibiotic-resistant infections following ERCP. At least 11 later died, but the report said the infections’ contribution to those deaths was unclear.

Researchers at Virginia Mason identified two related strains of multidrug-resistant E. coli in 32 patients between November 2012 and August 2013. Investigators recovered the outbreak strain from four of eight duodenoscopes and found no breach in the high-level disinfection protocol.

In 2017, a jury awarded Virginia Mason $6.6 million against Olympus over inadequate warnings. The hospital then paid the family $1 million, although a judge later ordered a new trial of the patient family’s claims.

UCLA Ronald Reagan Medical Center Outbreak (2014-2015)

UCLA’s February 2015 update reported that it had notified 179 patients who were potentially exposed to carbapenem-resistant enterobacteriaceae (CRE) after endoscopies. Seven patients were infected, and two died.

The hospital identified two Olympus scopes as potential sources of transmission despite following national and manufacturer-recommended cleaning standards.

Duodenoscopes contain small working parts that can retain tissue or fluid from a previous patient, making them difficult to clean. The moving forceps elevator at the tip and the spaces around it require particular attention during cleaning.

A laboratory assessment described in the 2018 Justice Department case identified cracks, corners and crevices at the Q180V tip that could harbor bacteria and be difficult to clean.

The FDA identifies narrow internal channels, hinges, O-rings and surfaces that cannot be separated for cleaning as design features that can retain biological material.

Olympus TJF-Q180V Redesign and Recall

In 2016, Olympus recalled the TJF-Q180V duodenoscope to replace the forceps elevator mechanism with a newly cleared design, and 4,436 devices sold in the U.S.were involved in the recall.

The FDA described the redesigned model as intended to reduce the risk of infection.

FDA Postmarket Surveillance Study Results

FDA-ordered sampling produced direct evidence that reprocessed duodenoscopes could still harbor organisms that may cause infection. The Olympus study’s final results found high-concern organisms in 4.1% of properly collected TJF-Q180V samples and 6.6% of TJF-160F/VF samples.

Earlier 2019 interim results, reproduced in a Senate oversight letter, reported high-concern organisms in 5.4% of properly collected samples.

By 2022, the FDA urged facilities to complete the transition to duodenoscopes with disposable components or fully disposable designs. The agency cited interim contamination of 0.5% for one removable-component model, compared with up to 6% for older models. Disposable components may reduce infection risk, but they do not eliminate it.

FDA regulatory findings and DOJ fines document problems in how Olympus evaluated devices and communicated potential harm.

In December 2018, Olympus Medical Systems pleaded guilty to distributing misbranded devices after reporting failures and was fined $80 million, plus $5 million in criminal forfeiture. The company pleaded guilty to DOJ charges that it failed to file FDA-required duodenoscope infection reports and continued to sell them despite these failures.

In January 2023, the FDA issued warning letters to Olympus for reporting and quality-system violations, including inadequate procedures and late adverse-event reports. A separate March 2023 warning letter criticized the response to approximately 160 complaints that a duodenoscope distal cover had fallen off.

In June 2025, the FDA announced import restrictions on certain Olympus devices due to unresolved quality-system concerns.

An October 2025 Olympus safety notice alerted health care providers to updated reprocessing materials for certain TJF duodenoscopes following reports of infections or positive bacterial cultures.

The company noted two death reports and five serious-injury reports since 2024, while saying they didn’t have enough information to determine whether the scope contributed to infections.

Editor Arsheeya Garg contributed to this article.