FDA Import Action Sharpens the Medical Questions in Olympus Scope Infection Cases

By Burton Bentley II, MD, FAAEM

These Olympus endoscope infection lawsuits raise important questions about medical causation and the evidence needed to establish whether a device transmitted an infection. The FDA has expanded an import alert covering certain Olympus endoscopes and related devices while several patients and families are pursuing claims that reusable Olympus scopes transmitted serious infections. The October 20 action does not decide those lawsuits, but it brings renewed attention to the records that will determine whether a scope was the source of a particular patient’s illness.

What Makes Reusable Endoscopes a Potential Infection Risk?

Endoscopes allow physicians to examine and treat areas of the body without open surgery. During an endoscopic retrograde cholangiopancreatography, or ERCP, a physician advances a specialized scope through the mouth to reach the bile and pancreatic ducts. The procedure can relieve an obstruction, remove a stone, or place a stent. Because the scope is reused, it must be cleaned and disinfected between patients through a process known as reprocessing.

That task is more difficult than it sounds. Some scopes have narrow channels and moving components that can retain biological material. A later infection may reflect contamination that survived reprocessing, but it may also arise from the patient’s underlying disease, a biliary obstruction, another procedure, an indwelling device, or exposure elsewhere in the hospital. The timing and microbiology matter as much as the diagnosis itself.

What Are the Allegations in the Olympus Endoscope Infection Lawsuits?

One pending case illustrates the stakes. In Bruto Da Costa v. Olympus America, filed June 5 in federal court in Washington, the complaint alleges that an Olympus TJF-Q190V duodenoscope was used during Mark Bruto Da Costa’s ERCP at the University of Washington Medical Center in June 2023. His estate alleges that he developed a vancomycin-resistant Enterococcus bloodstream infection, followed by septic shock, organ failure, and death. The complaint attributes the infection to the reusable scope. Olympus has not been found liable, and the allegation that this device transmitted the organism remains unproved.

A separate case, Nichols v. Olympus America, was removed to federal court in Pennsylvania on August 28. That wrongful-death action also concerns an infection allegedly following an ERCP. The docket identifies Olympus’s defense counsel, but the public filings reviewed for this article do not contain a ruling on defect or medical causation.

What Did the FDA’s October 2026 Olympus Import Alert Address?

The latest FDA action is broader than either lawsuit and must be read carefully. The agency’s import alert covers specified models of ureterorenoscopes, bronchoscopes, laparoscopes, automated endoscope reprocessors, enteroscopes, and capsule imaging systems made at Olympus facilities in Japan. It followed an October 7 warning letter in which the FDA described quality-system violations across multiple Olympus facilities. Olympus told the agency that it had opened corrective and preventive actions, revised procedures, and begun additional validation work. The FDA responded that many measures were still in progress or lacked evidence showing they were complete and effective.

Does the FDA Import Alert Establish Device Defect or Medical Causation?

At the same time, the FDA did not tell hospitals to stop using every Olympus device. It said devices already in service may continue to be used if they are functioning properly. The agency emphasized following the manufacturer’s reprocessing instructions, avoiding damaged devices or those that fail leak testing, and maintaining inspection and service schedules. The import alert also does not establish that the model named in a pending lawsuit was defective or that it caused an infection.

What Medical Evidence Is Needed to Evaluate Endoscope-Related Infections?

That distinction will shape the medical evidence. A case-specific review begins with the exact device and serial number, its service and reprocessing history, the procedure record, and any device or environmental cultures. It then turns to the patient: the organism involved, when symptoms began, prior hospital exposures, antibiotic use, biliary disease, immune status, other procedures, and alternative routes of infection. Molecular or strain matching may be powerful when available, but many cases will have to be evaluated from timing, exposure records, and competing clinical explanations.

Why Must Medical Causation Be Established in Each Olympus Infection Case?

The FDA’s action gives both sides important regulatory evidence, but it does not supply the missing causal link. That link must still be built, or challenged, patient by patient and device by device.

Sources

FDA’s October 20, 2026 Olympus Safety Communication

https://www.fda.gov/medical-devices/letters-health-care-providers/update-import-alert-certain-olympus-medical-devices-manufactured-japan-letter-health-care-providers

Bruto Da Costa v. Olympus America — Federal Docket

https://dockets.justia.com/docket/washington/wawdce/2:2026cv01977/363801

Frequently Asked Questions About Olympus Endoscope Infections and Litigation

1. What infections have been associated with contaminated endoscopes?

Contaminated reusable endoscopes may transmit serious bacterial infections. In Bruto Da Costa v. Olympus America, the complaint alleges a vancomycin-resistant Enterococcus (VRE) bloodstream infection following an ERCP procedure. Whether the endoscope transmitted the organism remains unproved.

2. Has the FDA recalled Olympus endoscopes because of infection risks?

Dr. Bentley’s article discusses the FDA’s October 20, 2026 import alert, rather than a product recall. The action covers specified Olympus medical devices manufactured in Japan and does not establish that every Olympus endoscope is defective or unsafe to use.

3. Can an ERCP procedure cause a serious infection?

Serious infections can occur following ERCP procedures, but the source of an infection is not always clear. Potential explanations include contaminated equipment, underlying biliary disease, obstruction, indwelling devices, or other hospital exposures.

4. What evidence can help determine whether an Olympus endoscope transmitted an infection?

Relevant evidence includes the device’s serial number, reprocessing and service history, procedure records, microbiological cultures, and the patient’s clinical history. Molecular or bacterial strain matching may provide additional evidence when available.

5. What medical experts may be needed in Olympus endoscope infection lawsuits?

Dr. Bentley’s article identifies several areas requiring medical evaluation, including infection mechanisms, microbiological findings, endoscope reprocessing, and patient-specific medical causation. The appropriate expertise depends on the clinical issues and evidence involved in each case.