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Lawsuit Filed over Death of Patient who Contracted Fatal Superbug, Allegedly Due to Pentax Scope

Sep 3, 2015

A wrongful death lawsuit has been filed in connection with the superbug outbreaks linked to contaminated duodenoscopes. The suit, which was filed on August 31, 2015 in state court in Cook County, Illinois, alleges that Pentax Medical, a division of Pentax of America, Inc. and Advocate Lutheran General Hospital were negligent with regards to a fatal superbug infection linked to the specialized scope. On December 3, 2013, a woman died from carbapenem-resistant Enterobacteriaceae (CRE), an antibiotic-resistant bacteria. She had undergone Endoscopic Retrograde Cholangiopancreatography or ERCP at Advocate Lutheran General Hospital using a Pentax duodenoscope.

The lawsuit alleges that the scope was defectively designed, making it extremely difficult to sterilize certain parts. The suit also alleges that Advocate Lutheran General Hospital failed to properly clean the devices; the tainted scopes were linked to infections in 43 other patients, the suit alleges.

Duodenoscopes are snaked down the esophagus and into the first portion of the small intestine to visualize and treat certain medical conditions, such as gallstones. The devices came under scrutiny in light of several superbug outbreaks, one of which occurred at Ronald Reagan UCLA Medical Center in Los Angeles. There was also an outbreak at Cedars-Sinai Medical Center.

In February, the U.S. Food and Drug Administration (FDA) warned that the complex design of duodenoscopes can prevent them from being adequately sterilized, and that the devices could transmit antibiotic-resistant bacteria between patients. Last month, the FDA sent warning letters to scope makers Olympus, Pentax and Fujifilm for either failing to adequately report problems or failing to validate their cleaning methods.

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