Olympus Endoscope Lawsuit Filed Over ERCP Infection, Sepsis Linked to Contaminated Scope

Lawsuit alleges Olympus knew reusable scopes could remain contaminated after cleaning, exposing ERCP patients to risks of dangerous infections, sepsis and death.

Years after an industry shake-up over duodenoscope infections changed the devices’ designs and how they are sanitized, a lawsuit filed by the widow of a Washington man links an Olympus scope to infections after an ERCP (endoscopic retrograde cholangiopancreatography) and her husband’s death.

Michelle Bruto Da Costa brought the complaint (PDF) in the U.S. District Court for the Western District of Washington on June 5, pursuing claims against Olympus Corporation and multiple subsidiaries for designing and manufacturing a defective medical device, as well as failing to warn doctors or patients about the potential risk of ERCP infections from the endoscope.

According to the lawsuit, Bruto Da Costa’s husband, Mark Bruto Da Costa died on June 28, 2023, after being diagnosed with vancomycin-resistant Enterococcus (VRE). His infection and death was allegedly caused by a contaminated Olympus endoscope, which spread the infection to him during the procedure

Endoscope, Colonoscopy and ERCP Infections

Duodenoscopes and other endoscopes are reusable medical scopes used during procedures such as ERCP, colonoscopy, upper endoscopy and bronchoscopy. The devices, which are manufactured by Olympus, Fujifilm and others, contain small cameras, lights, long narrow channels and moving parts that allow doctors to examine internal organs, diagnose medical conditions and perform certain treatments without open surgery.

More than 22 million gastrointestinal endoscopic procedures are performed in the United States every year, including roughly 15 to 19 million colonoscopies and more than 650,000 ERCP procedures. An estimated 50 million colonoscopies are performed annually around the world. Since these devices are often used on multiple patients, the scopes must be thoroughly cleaned, disinfected and reprocessed after each procedure.

However, lawsuits and safety investigations have raised concerns that 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.

As a result, Olympus scope infection lawsuits are now being filed over allegations that contaminated reusable endoscopes were defectively designed, because they could not be reliably cleaned and sanitized even when hospitals followed the manufacturer’s reprocessing instructions. Plaintiffs claim these design and warning failures exposed patients to serious bacterial infections, sepsis, organ failure and in some cases, even death.

Olympus Scope Infection Allegations

The new lawsuit indicates Mark Bruto Da Costa underwent an endoscopic retrograde cholangiopancreatography, known as ERCP, on June 12, 2023, at the University of Washington Medical Center in Seattle. The procedure involved the use of an Olympus TJF-Q190V duodenoscope.

Four days later, on June 16, Bruto Da Costa presented for paracentesis, and blood cultures were obtained showing gram-positive cocci. On June 18, an infectious disease specialist noted that Bruto Da Costa had taken “a definitive turn for the worse,” with significant weight loss, persistent leukocytosis and worsening hyperbilirubinemia.

The complaint alleges VRE was not present on any of Bruto Da Costa’s extensive bloodwork before the June 12 ERCP procedure using the Olympus duodenoscope. Plaintiffs claim he acquired VRE from the endoscope device, and that the infection could not be eradicated despite varied efforts and treatment.

Bruto Da Costa died on June 28, 2023. His wife’s lawsuit alleges he died due to organ failure and septic shock caused by VRE introduced by the Olympus endoscope device.

The lawsuit accuses Olympus of failing to address contamination issues and update the design of its endoscopes adequately enough to prevent infections, despite years of knowing there were problems with reusable scope devices.

The complaint notes that a 2022 post-market surveillance study ordered by the FDA found only 34.8% of sampled endoscopes contained no contamination at all.

“Defendants knew or should have known that available research has demonstrated that, using magnification and borescopes inspection, 100% of endoscopes with narrow channels, like Defendants’ Endoscope, showed visible damage, residue, and/or debris, requiring repair 76% of the time. In endoscopes, like Defendants’ Endoscope, channel shredding, scratches, and/or defects appear within a few uses, requiring repair. These grooves and defects allow buildup of biofilm and the proliferation of bacteria.”

– Michelle Bruto Da Costa v. Olympus America Inc. et al.

The lawsuit further alleges Olympus failed to recommend or require additional monitoring tools that could detect contamination, moisture or damage inside reusable scopes, including borescope inspections, dryness indicator tests, adenosine triphosphate testing and microbial culturing.

Plaintiffs claim the Olympus endoscope’s narrow channels, complex tip, forceps elevator and repeated use made it difficult to clean, allowing bacteria to survive reprocessing and transfer to later patients.

Olympus Endoscope Defect and Failure to Warn Claims

Bruto Da Costa’s wife presents claims of defective design, failure to warn, manufacturing defect, negligence, gross negligence, breach of warranty, negligent infliction of emotional distress, negligent misrepresentation, fraud and fraudulent misrepresentation, fraudulent concealment, outrage, loss of consortium and wrongful death.

The lawsuit argues Olympus failed to warn doctors, patients and medical providers that its endoscope devices could harbor microorganisms, including multidrug-resistant organisms, even after users followed the company’s reprocessing instructions.

The complaint also alleges Olympus failed to disclose the severity of complications that could arise from contaminated endoscope use, including severe infection, sepsis, organ failure, septic shock and death.

According to the lawsuit, Olympus represented that its devices were safe and effective for endoscopic procedures, while allegedly minimizing or concealing the true risks. Plaintiffs argue that if Bruto Da Costa or his healthcare providers had been properly warned about the dangers, the Olympus device would not have been used.

The complaint seeks compensatory and punitive damages, as well as damages for wrongful death, loss of consortium, medical expenses, funeral expenses, pain and suffering, emotional distress and other losses.

Olympus Scope Infection Lawsuits

Olympus scope infection lawsuit lawyers are reviewing claims for individuals nationwide who suffered serious infections after an ERCP or other endoscopic procedure involving a potentially contaminated reusable scope.

You may be eligible to file a claim if you or a loved one suffered any of the following after a colonoscopy, endoscopy, ERCP or bronchoscopy:

• Sepsis
• Bloodstream infections
• Pneumonia
• Organ failure
• Wrongful death
• Extended hospitalization
• Emergency medical treatment
• E. coli or other bacterial infections
• Carbapenem-resistant Enterobacteriaceae (CRE)
• Blood-borne infections, including HIV or tuberculosis
• Exposure to drug-resistant bacteria or infectious diseases

All contaminated scope infection lawsuits are handled on a contingency fee basis. This means there are no upfront costs to have a lawyer investigate your potential claim, and no legal fees or expenses are paid unless a settlement or recovery is obtained.

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