June 29, 2015 — A woman from Newport Beach, California has filed a lawsuit blaming the manufacturer of a hard-to-clean endoscope for her antibiotic-resistant infection.
Staci Simos filed the lawsuit in Los Angeles Superior Court against Olympus Corp., manufacturer of the Q180V duodenoscope that was used in a procedure she underwent at UCLA hospital last October.
Officials at UCLA’s Ronald Reagan Medical Center have notified 179 patients that they may have been exposed to antibiotic-resistant bacteria during endoscopic procedures between October and January 2014. At least seven people were infected, including two who died.
Simos is at least the fourth person to file a lawsuit. She allegedly developed Carbapenem resistant Enterobacteriaceae (CRE), an antibiotic-resistant “superbug” that is extremely difficult to treat.
According to the Orange County Register:
“After each use, the Q180V scope necessarily requires cleaning and disinfecting before it can be used on a new patient. 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,” according to the complaint. The lawsuit accuses Olympus of negligence for failing to ensure it could be adequately sterilized between uses.
In May, the FDA warned that duodenoscopes are extremely difficult to sterilize because they have complex mechanisms in the tip. The FDA has also reported that the Olympus Q180V scope had been on the market since 2010 without proper clearance.