On November 20, 2015, a wrongful death lawsuit was filed in the U.S. District Court for the Eastern District of Pennsylvania against Olympus America, Olympus Medical Systems Corp., and Custom Ultrasonics, alleging that the Olympus TJF-Q180V (“Olympus 180”) duodenoscope was defectively designed so that it made it difficult to properly clean between procedures, including before a procedure performed on a man in North Carolina on January 11, 2013, during which the man contracted a very serious bacterial infection that led to his painful death just over eight months later.
The wrongful death lawsuit alleges that the man contracted CRE (Carbapenem-resistant Enterobacteriaceae, a so-called “super bug”) during a routine ERCP (Endoscopic Retrograde Cholangiopancreatography) due to the unsafe nature of the Olympus 180 and the manufacturer’s failure to warn that the device could not be adequately cleaned.
The wrongful death lawsuit alleges that the Carolinas Medical Center (“CMC”), where the man had his procedure performed, used a cleaning device known as an AER (automated endoscope reprocessor) manufactured by Custom Ultrasonics to clean the Olympus 180 (as well as other endoscopes) but that the AER inadequately sterilized or disinfected the Olympus 180 due to the unsafe design of the scope.
The man died as a result of his CRE infection on November 24, 2013, after suffering excruciating pain, losing 60 pounds, enduring multiple hospitalizations, requiring external wound drainage, and requiring a feeding tube for nutrition. He also experienced delirium and oxygen deprivation. He was relegated to isolation due to the highly contagious nature of CRE, thereby depriving him from physical contact with his family. The 55-year-old former cement mixer driver wasted away to the point that he became frail and weak and he was unable to perform the activities of daily living on his own.
The FDA issued a Safety Communication on February 19, 2015 that warned that the inherent design of the Olympus 180 (as well as other ERCP endoscopes) impedes the effective cleaning of the scopes, and that multi-drug-resistant bacteria (super bugs) could be transmitted by the endoscope even when the manufacturer’s cleaning instructions were correctly followed.
The FDA issued an additional Safety Communication on November 13, 2015, ordering Custom Ultrasonics to recall all of its AERs from health care facilities due to its continued violations of federal law and a consent decree entered with the company in 2007, and recommending that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative methods to reprocess flexible endoscopes as soon as possible. An estimated 2,800 AERs manufactured by Custom Ultrasonics are currently in hospitals and outpatient clinics throughout the United States. The FDA’s recall order applies to all Custom Ultrasonics AERs, including the System 83 Plus, System 83 Plus 2 and System 83 Plus 9.
The FDA notes that more than 500,000 ERCP procedures using duodenoscopes are performed in the United States annually, which is the least invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other conditions. Duodenoscopes, which are flexible, lighted tubes, are threaded through the mouth, throat, stomach, and into the top of the small intestine (the duodenum). Duodenoscopes contain a hollow channel that allows the injection of contrast dye or the insertion of other instruments to obtain tissue samples for biopsy or treat certain abnormalities. Unlike most other endoscopes, duodenoscopes also have a movable “elevator” mechanism at the tip. The elevator mechanism changes the angle of the accessory exiting the accessory channel, which allows the instrument to access the ducts to treat problems with fluid drainage. Although the complex design of duodenoscopes improves the efficiency and effectiveness of ERCP, it causes challenges for cleaning and high-level disinfection. Some parts of the scopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be possible.
According to the FDA’s November 13, 2015 News Release, its most recent inspection of Custom Ultrasonics’ facility in April 2015 documented continued violations, including the inability to validate that the AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection. In the months following the inspection, the FDA provided the company with an opportunity to correct inspection violations and requested additional validation data. Following a review of the company’s submissions, the FDA determined that Custom Ultrasonics has not adequately addressed its continued violations, which could result in an increased risk of infection transmission to patients.
If you or a family member acquired a serious infection following an endoscopic procedure, you should promptly consult with a local medical malpractice lawyer in your U.S. state who may investigate your possible endoscopy claim for you and represent you in a claim for compensation due to the injuries you suffered following an endoscopy.
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