A Newport Beach woman sued a medical device maker Friday, blaming the company for the outbreak of a superbug at Ronald Reagan UCLA Medical Center that infected her and at least six other patients, killing two.

Photo by John Schreiber.

Staci Simos filed the lawsuit in Los Angeles Superior Court against Olympus America Inc., saying she acquired the superbug known as CRE after she underwent a procedure last October at UCLA in which doctors used the Q18OV scope.

Her husband, Michael Simos, also is a plaintiff.

The suit alleges products liability, negligence and fraud and seeks unspecified damages.

At least three other lawsuits related to the superbug outbreak were filed against Olympus in February and March.

Olympus spokesman Mark Miller previously said the company did not seek approval for changes made to the device because, according to FDA policy on modifications, it was not required to do so.

The Simos suit states, however, that the device-maker had responsibilities to patients such as Simos.

“After each use, the Q18OV scope necessarily requires cleaning and disinfecting before it can be used on a new patient,” the suit states. “A manufacturer of a medical device like an endoscope … has an obligation to develop and validate a (cleaning) protocol and to incorporate this protocol into the product’s labeling.”

Olympus “failed to take these critical steps with the redesigned Q18OV scope,” the suit alleges.

The suit does not blame UCLA for the outbreak. UCLA officials said earlier this year that they notified 179 patients who underwent endoscopic procedures between October and January that they may have been exposed to the superbug. Officials at the Westwood hospital traced the infections to a pair of Olympus scopes.

The device-maker’s website carries a cleaning video and says:

Olympus shares the public concern regarding reports connecting duodenoscopes to infections by drug resistant bacteria, specifically CRE or carbapenem-resistant Enterobacteriaceae. We express our sympathy to those who have experienced these infections.

Olympus remains committed to developing solutions for healthcare professionals that help improve clinical outcomes and enhance quality of life for their patients. We continuously strive to improve our medical devices for safe and effective use.

— From staff and wire reports

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