Instead, legal allegations are pointing at the endoscopes and potentially substandard cleaning instructions published by manufacturer Olympus Corporation as the cause of the life-threatening problem. Multiple media outlets report that the Olympus Corporation which manufactured the endoscopes linked to the deadly superbug infections never obtained approval from the Food and Drug Administration (FDA) for the device. As a result, it is alleged that the cleaning instructions that accompanied the scopes in question was inadequate.
CNN reported that an internal review at the Ronald Reagan UCLA Medical Center found that the cleaning protocols set by the FDA and scope manufacturers still didn't remove the superbug from the devices. In fact, the superbug was "embedded" in the scopes even after cleaning, said Dr. Robert Cherry, chief medical and quality officer of the UCLA Health System.
The scope arrived on the market in 2010, and stayed on the market for more than four years before the FDA realized the device was never cleared. A picture of the Olympus TJF-Q180V scope implicated in the most recent CRE outbreaks is pictured below.
Duodenoscopes are most commonly used to do procedures on the gallbladder, pancreatic ducts, and the bile ducts, which are a series of thin tubes that reach from the liver to the small intestine.
Attorney Brendan Lupetin of Pittsburgh based Meyers Evans & Associates has filed the first lawsuit in Pennsylvania against Olympus Corporation for injuries sustained by a local woman as a result of contracting the deadly CRE superbug as a result of exposure to an Olympus duodenoscope. Lupetin has been previously interviewed by the Associated Press in regards to an earlier outbreak of CRE. The complaint has been filed in the Court of Common Pleas of Allegheny and can be read in full below.
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