Contaminated Olympus Endoscope Lead to Outbreak of Fatal Bacterial Infections
Olympus’ Surgical Scope Exposes Patients to Risk of Infection
Medical device manufacturer Olympus Medical Systems Corp. (Olympus) is under investigation because its surgical device has been linked to serious infections, including some strains of drug-resistant bacteria known as “superbugs.”
Olympus manufactures and sells a device called a duodenoscope that is used in endoscopic retrograde cholangiopancreatography procedures (ERCP). In an ERCP, the scope is guided down the patient’s throat and used to examine the digestive system. Olympus sells its device for use and re-use with multiple patients. The problem is that the Olympus endoscope is difficult to clean and can spread infection with deadly bacteria.
Outbreaks of infection have been linked to contaminated Olympus duodenoscopes at several hospitals around the country. For example, in early 2016, nine patients were reported to develop an E.Coli infection after endoscopy procedures at the University of Colorado Hospital. An investigation determined that nine of 19 patients who underwent procedures with the same duodenoscope over a six-week period developed antibiotic-resistant E.coli infection.
Over the past several years, there have been several outbreaks affecting hundreds of patients in states across the U.S., including California, Colorado, Illinois, Pennsylvania, and Washington. Not only do these “superbugs” harm the infected patients, but, according to the Centers for Disease Control and Prevention, spread of antibiotic-resistant strains of bacteria is also a serious threat to public health.
Olympus Knew of the Risk; Failed to Protect U.S. Patients
The FDA sent Olympus a Warning Letter on August 12, 2015 stating that the company had failed to properly inform the FDA that patients contracted infections after undergoing endoscopic procedures with the Olympus device. According to the FDA, Olympus knew about these infections as early as May 16, 2012. However, despite its awareness of this risk to patients, the company failed to take proper action to notify the FDA and take steps to ensure that other patients were not being exposed to this risk.
Olympus issued a safety alert in Europe in January 2013 advising the medical community about the concern that the device could not be de-contaminated sufficiently to prevent infection. According to a recent news report, when U.S. employees inquired whether it was necessary to give a similar warning in the U.S., the company leadership said it was not necessary and that the risk to patients was “acceptable”.
Olympus failed to take steps to notify U.S. hospitals and surgeons of this risk until early 2015, and then only after the media reported that patients a U.S. hospitals were at risk. As a result, hundreds of patients have been exposed to this avoidable risk, including many who were infected and some who died.
Burg Simpson is investigating claims on behalf of individuals who developed serious bacterial infections after undergoing endoscopic retrograde cholangiopancreatography (ERCP) with the Olympus scope. Please contact us at 303-792-5595 for more information, or fill out the Free Case Evaluation form.
CNBC: 35 deaths linked to scope infections after Olympus told execs not to warn hospitals