In an attempt to reduce the spread of bacteria between patients, Olympus redesigned and modified its duodenoscope medical devices last year. However, the U.S. Food and Drug Administration (FDA) now reports that five patients were infected with deadly bacteria after being treated with the updated devices, which were approved by the FDA in early 2016.
The deadly “superbug” infection outbreak began in 2015 at the Huntington Hospital in Pasadena, where sixteen patients developed severe bacterial infections, and 11 of those patients died. Additional outbreaks followed in hospitals and clinics throughout Southern California, including UCLA Ronald Reagan Medical Center.
The $40,000 medical scope instrument known as a duodenoscope consists of flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum) and utilized in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) examination procedures. If the devices are not properly cleaned and disinfected, tissue or fluids from one patient can remain in the medical scopes and be inadvertently transferred to another patient.
The most recent infection outbreak from the modified scopes happened in December in an unnamed health facility in another country. With respect to the earlier infections, as reported in a series of Los Angeles Times stories, “Olympus knew of the potential flaws in the scope as early as the spring of 2012, following an infection outbreak in the Netherlands, but failed to alert American hospitals or regulators until after the UCLA outbreak in February 2015.”
Although Olympus engineers had worked to change the medical scope design so that it would make the cleaning procedure easier, three independent investigations of the new design revealed that the modified scopes could still allow bacteria to remain after being cleaned to Olympus’ standards.
As noted by the Times, “American hospitals are currently using about 4,400 of the devices that Olympus voluntarily recalled last year to replace a small mechanism linked to deadly outbreaks around the world.”
Contact an Endoscope Infection Personal Injury Attorney
Lieff Cabraser has successfully represented thousands of patients across America injured by defective and dangerous medical devices. We currently represent patients who developed “Superbug” CRE infections after undergoing endoscopic retrograde cholangiopancreatography (ERCP), as well as the families of patients who died as a result of such infections.
If you or a family member developed CRE following an endoscopic procedure, please contact an experienced injury lawyer at Lieff Cabraser to discuss your case. You can also call us toll-free at 1 800 541-7358 and ask to speak to injury attorney Lexi Hazam or Wendy Fleishman. There is no charge or obligation for our review, and your information will be held in the strictest confidence.