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Redesigned Olympus Scope Linked to Infection Outbreak

Olympus issued a recall of its TJF-Q180V duodenoscope model in January 2016, after reports linked the device to multiple outbreaks of Carbapenem-resistant enterobacteriaceae (CRE), a form of antibiotic resistant infection that is difficult to treat, and often fatal. Further investigation into the incidents revealed that at least 35 people died after suffering infections linked to contaminated Olympus scopes, with the first reports of fatalities submitted as early as 2013.

Duodenoscopes are used in more than 500,000 gastrointestinal endoscopic procedures each year. These devices are used during endoscopic retrograde cholangiopancreatography (ERCP) procedures to diagnose and treat conditions within the bile duct and main pancreatic duct, such as gallstones and cancer. The duodenoscope can be used to drain fluid from biliary and pancreatic ducts that are blocked by tumors, gallstones or other conditions affecting the gastrointestinal system.

The Olympus duodenoscope recall notice requested that hospitals return the affected devices so the manufacturer could institute a broad-scale replacement of certain parts. The redesigned parts were intended to make the duodenoscopes easier to clean—as the previous design of the devices enabled bacteria to be stored due to the difficulty of keeping small crevices in the devices sanitized.

However, questions are now being raised as to whether the changes made to the device have been substantial enough, as a report filed with the FDA claims there have been new outbreaks of the CRE infection reported in a foreign health facility using the remodeled Olympus duodenoscope.  The FDA filing, submitted in December 2016, indicated that five patients at the hospital tested positively for a strain of antibiotic resistant infection.

Over the past two years, Olympus, among two other duodenoscope manufacturers, has faced scrutiny by consumers and government agencies who claim that the company displayed negligent behavior in correcting the flawed device. Critics have cited several independent investigations which assert that Olympus manufacturers were aware of flaws in their duodenoscope design as early as spring of 2012, but chose not to recall the devices until long after hospitals began reporting infections. Critics have also suggested that regardless of changes made to design, devices are still capable of transmitting bacteria from patient to patient, even after sanitizing per Olympus guidelines.

Lawsuits are now being filed by patients, and their families, who contracted CRE and other antibiotic resistant infections after undergoing routine endoscopic procedures using a duodenoscope.  If you or a loved one suffered from severe abdominal pain, gallstones, pancreatic cancer, or biliary or pancreatic duct obstructions between 2012 and 2015, and underwent an ECRP procedure using a duodenoscope, you may be able to seek legal redress. Contact the attorneys at the Law Offices of Peter Angelos, P.C., for a no-cost legal consultation.