June 29, 2015 — Olympus Corp. has been hit with another lawsuit after deadly outbreak of antibiotic-resistant infections was traced to a hard-to-clean medical scope that was sold without clearance from the FDA.
The lawsuit was filed in Los Angeles Superior Court by Staci Simos, a woman from Orange County, California. She was diagnosed with Carbapenem resistant Enterobacteriaceae (CRE), an antibiotic-resistant “superbug,” after undergoing a procedure at UCLA’s Ronald Reagan Medical Center.
Earlier this year, UCLA notified 179 people that they may have been exposed to CRE on dirty duodenoscopes. At least seven were infected and two died. Simos is at least the fourth person to file a lawsuit against Olympus Corp. for failing to provide hospitals with adequate instructions for cleaning the scope.
The Orange County Register reports that the lawsuit states:
“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.”
The lawsuit also claims that Olympus “failed to take these critical steps with the redesigned Q18OV scope.”
Lsat month, the FDA warned that all duodenoscopes were very difficult to clean due to complex mechanisms in the tip of the scope. The FDA did not issue any recalls, but did report that Olympus’s Q180V scope has been on the market since 2010 without proper clearance.