April 6, 2015 — Olympus Medical has been hit with a lawsuit from a woman who was diagnosed with a serious infection after she was treated at Allegheny General Hospital in Pennsylvania, according to the Pittsburgh Tribune.
The lawsuit was filed by Elsie Florian, a 76 year-old woman who was exposed to a contaminated endoscope between February 23 and March 4. She developed a highly antibiotic-resistant “superbug” infection and blames Olympus for failing to provide her hospital with safe cleaning procedures for the scope.
Florian claims Olympus failed to include a label about proper cleaning and disinfection procedures when they redesigned the Q180V endoscope in 2014.
The lawsuit alleges that a similar scope was linked to an outbreak of infections in patients in Washington state in 2013. In that outbreak, at least four patients died from infections transmitted on contaminated scopes.
According to the complaint:
“Any patient who underwent a medical procedure with a contaminated scope was exposed to serious health risks, including severe infection and death.”
In March 2015, Olympus updated the cleaning procedures for the duodenoscope model TJF-Q180V.
According to the FDA, the scope has been on the market since 2010 without proper clearance, and its application is still pending. Olympus has also failed to provide data proving that the scope can be disinfected to the agency’s standard.
In February 2015, the FDA warned that the complex design of the ERCP endoscopes (also called duodenoscopes) could impede effective cleaning. The warning was issued after the scopes were linked to a “superbug” outbreak at UCLA’s Ronald Reagan Medical Center in Los Angeles.