Infection After Colonoscopy Lawsuit — Your Legal Rights Against Olympus

Can Olympus Colonoscopes Spread Infection?

Yes. Olympus colonoscopes are complex, flexible hollow instruments that cannot be heat-sterilized — only chemically disinfected through a process called high-level disinfection (HLD). This limitation applies to all flexible endoscopes, including colonoscopes. A colonoscope’s biopsy and suction channels are difficult to reprocess and are a well-documented site of persistent contamination. At a Dutch tertiary-care hospital, an 8-year retrospective study of duodenoscopes — instruments that share the same biopsy and suction channels as colonoscopes — confirmed those channels as the primary contamination sites, with patient-origin bacteria (MGO) rates ranging from 14.3% to 47.5% annually across the study period (Source: van der Ploeg et al., Gut, March 2024, PMID 38182137, DOI: 10.1136/gutjnl-2023-330355).

Standard high-level disinfection leaves approximately 15% of patient-ready duodenoscopes contaminated with gastrointestinal bacteria even when hospital staff follow manufacturer instructions exactly (Source: Larsen S, et al., EClinicalMedicine. 2020;25:100451. PMID: 32954234). Colonoscopes fare no better: a 2022 systematic review and meta-analysis found colonoscope working channels contaminated at a pooled rate of roughly 32% — more than double the duodenoscope rate — even after manufacturer-recommended reprocessing (Source: Goyal H, et al., Endoscopy International Open. 2022;10(06):E840–E853.

PMID: 35692921). The contamination problem documented in ERCP duodenoscopes — where Olympus’s cleaning instructions proved repeatedly inadequate — stems from the elevator mechanism unique to duodenoscopes; colonoscopes do not have that mechanism, but they share the more basic vulnerability that all flexible endoscopes cannot be heat-sterilized and must be reprocessed by chemical high-level disinfection alone.

Approximately 15 to 19 million colonoscopies are performed annually in the United States, making colonoscopy the most widely performed endoscopic procedure. Given Olympus’s 70–80% U.S. endoscope market share, the majority of these procedures involve Olympus equipment. Colonoscopes are a qualifying device class per the co-counsel determination (April 6, 2026).

What Is the Olympus Scope Lawsuit and How Does Colonoscopy Fit In?

Olympus Corporation — the Japanese manufacturer that supplies the majority of endoscopes used in U.S. hospitals — is the subject of pending product liability litigation arising from infections caused by its contaminated scope equipment. The litigation covers multiple Olympus device classes, including duodenoscopes (used in ERCP procedures), bronchoscopes (used in lung procedures), and upper GI endoscopes (gastroscopes).

Colonoscopes are a qualifying device class under the same co-counsel framework. In December 2018, Olympus Medical Systems Corporation pleaded guilty to three counts — and former senior executive Hisao Yabe to one count — of distributing misbranded medical devices. The company paid $85 million in criminal penalties and admitted to failing to file required adverse-event reports with the FDA (Source: DOJ Press Release, December 10, 2018; Case No. 2:18-cr-00727-SRC, U.S. District Court, D.N.J.).

In October 2025, Olympus issued an Urgent Field Safety Notice updating its reprocessing instructions for current-generation TJF-series scopes and recommending 10X-magnification inspection. The company confirmed 2 deaths and 5 serious injuries linked to current-generation scopes and disclosed that hospitals were required to use 10X magnification tools to properly inspect the scopes — tools they had never previously been told were necessary (Source: Olympus Urgent Field Safety Notice, October 2025).

The U.S. Senate HELP Committee estimated at least 250 patients worldwide contracted potentially deadly infections from contaminated Olympus duodenoscopes, noting this figure is likely a significant undercount (Source: Senate HELP Committee, January 13, 2016). As the contamination mechanism and manufacturer failure extend to all Olympus flexible endoscope classes, colonoscopy patients who meet the qualifying criteria may pursue claims under the same litigation framework.

What Did Olympus Know About Colonoscope Contamination?

The contamination evidence that applies to Olympus duodenoscopes applies equally to all Olympus flexible endoscopes. The 8-year Dutch tertiary-care hospital study (van der Ploeg et al., Gut, 2024, PMID 38182137) found that all manufacturer-recommended interventions — disposable endcap designs, new automated reprocessing machines, and staff audits — failed to produce a meaningful reduction in contamination rates across the entire 8-year study period.

This failure applied to the biopsy and suction channels used in colonoscopy specifically. The chronological enforcement record reinforces this pattern: the FDA issued its first public warning in February 2015; in March 2018 it documented that Olympus had established zero postmarket surveillance sites after two years of mandatory orders; and in October 2025 Olympus updated its reprocessing instructions and recommended 10X-magnification inspection.

The October 2025 Urgent Field Safety Notice — covering TJF-series scope models — reflects ongoing concerns about the adequacy of Olympus’s scope reprocessing instructions. The legal argument in this litigation is that Olympus — not the hospital — was responsible for providing safe cleaning instructions. Hospitals reported following the reprocessing instructions provided by Olympus at the relevant time.

Whether those instructions were adequate, and whether they were in fact followed in every case, are contested issues that have been examined in litigation and in 2016 Senate HELP Committee findings. The litigation alleges Olympus knew those instructions were inadequate and failed to warn hospitals and patients.

What Qualifying Injuries May Support a Legal Claim After Colonoscopy?

To evaluate whether you may have a legal claim following a colonoscopy, the confirmed qualifying criteria are:

• The procedure must have occurred on or after January 1, 2015.
• Procedures performed with Olympus colonoscopes qualify. Olympus CF-series and PCF-series colonoscopes are used in the majority of U.S. colonoscopy procedures.
• A confirmed infection diagnosis is required.
• Inpatient hospitalization for the infection is required. Outpatient treatment with oral antibiotics alone does not qualify.
• IV antibiotic treatment during hospitalization is required.
• The infection and resulting hospitalization must have occurred within 30 days of your colonoscopy. Most patients in this litigation developed symptoms within approximately five days.
• You must not have been undergoing dialysis or chemotherapy at the time of your hospitalization.

If the scope or any component broke apart during your procedure and required emergency surgery to remove fragments, this may represent a separate product liability claim — contact us to discuss your situation. Even if you believe your filing deadline may have passed, contact us before assuming you have no options.

What Should I Do If I Developed an Infection After a Colonoscopy?

If you developed an infection following a colonoscopy, the following steps can protect your legal rights:

1. Request your colonoscopy procedure records. Ask for the procedure report identifying the specific Olympus scope model used. Colonoscope model numbers to look for on your procedure record include Olympus CF-series and PCF-series colonoscopes. Record the facility name, date, and performing physician.
2. Preserve your infection records. Obtain all records from your hospitalization: blood culture results, the specific organism identified, antibiotic treatment records, and discharge documentation. The organism name and its resistance profile are the primary evidence connecting your infection to a contaminated scope.
3. Note the timing. Record the exact date of your colonoscopy and the date your infection symptoms began or was diagnosed. The 30-day window from procedure date is the critical threshold.
4. Do not contact the hospital about a legal claim without consulting an attorney first. Statements made to the hospital could affect your case.
5. Contact Marin & Murphy. Our attorneys evaluate Olympus scope infection claims for patients in Rhode Island, South Carolina, Connecticut, and Massachusetts, and associate with locally licensed co-counsel to pursue claims nationwide. The consultation is free.

Marin & Murphy Law Firm is investigating Olympus scope infection claims for patients in Rhode Island, South Carolina, Connecticut, and Massachusetts. Contact us at (888) 348-2735. The consultation is free and creates no obligation.

Sources

1. FDA: Infections Associated with Reprocessed Duodenoscopes
2. FDA: Two Warning Letters to Olympus Over Endoscope Reprocessing
3. U.S. Senate HELP Committee Report on Duodenoscopes
4. CDC: About Carbapenem-resistant Enterobacterales (CRE)
5. Larsen S, Russell RV, Ockert LK, Spanos S, Travis HS, Ehlers LH, Mærkedahl A. Rate and impact of duodenoscope contamination: A systematic review and meta-analysis. EClinicalMedicine. 2020 Jul 15;25:100451. doi:10.1016/j.eclinm.2020.100451. PMID: 32954234. PMCID: PMC7486302.