April 6, 2015 — A woman from Pennsylvania has filed a lawsuit after she was diagnosed with an antibiotic-resistant “superbug” infection transmitted on an Olympus duodenoscope during a procedure at Allegheny General Hospital in Pittsburgh.
The Pittsburgh Tribune reports that the lawsuit was filed by 76 year-old Elsie Florian, who was infected after endoscopic procedures between February 23 and March 4.
She accuses Olympus of negligence for failing to provide her hospital with adequate instructions for cleaning the Q180V scope, which was re-designed in 2014. 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.”
The lawsuit also claims Olympus knew or should have known about the risk of disease-transmission because a similar scope was responsible for a “superbug” outbreak in Washington state that killed four people in 2013.
Olympus updated the instructions for cleaning the endoscope, model TJF-Q180V, in March 2015.
The scope has been on the market since 2010 without approval from the FDA, and the approval application is still pending. Since last year, Olympus has failed twice to prove that their disinfection protocol can kill 99.9999% of microbes, which is the FDA’s standard.
Unlike typical endoscopes, the Q180V is a duodenoscope and has a complex “elevator” mechanism in the tip. The FDA has warned that the complex design of the scope may impede effective sterilization, which could potentially lead to disease-transmission among patients.