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Medical Device Not Approved by FDA Causes Bacteria Outbreak

A endoscope manufactured by Olympus was responsible for the outbreak of superbug “CRE” (or carbapenem-resistant Enterobacteriaceae), which was transmitted during certain endoscopy procedures. CRE is rare but has recently caused two patient fatalities and about seven patient infections at the UCLA Medical Center in California. In addition, as many as 180 patients might have been exposed between early October 2014 and late January 2015, according to CNN and other news sources).

The Centers for Disease Control (CDC) says that CRE infections are tough to treat because it’s highly resistant to certain drugs and antibiotics. “E-coli” is a well-known example. Symptoms include pneumonia, severe urinary tract infections (UTIs), high fever, sepsis (blood poisoning) and septic shock (very low blood pressure). According to the CDC, this superbug more frequently affects patients in acute or long-term healthcare settings, like hospitals.

The medical device is Olympus America’s TJF-Q180V duodenoscope, “[a] flexible, lighted tube which threads through the mouth, throat, stomach, and into the top of the small intestine” using fiber optics for visual examination, according to the FDA. Over 500,000 procedures using duodenoscopes are performed annually in the U.S.

Most troubling is Olympus never actually obtained FDA approval to market the scope.

In recent years, Olympus redesigned the scope to improve and make it safer for patients. Unfortunately this had the opposite effect. The channel in the “ movable elevator mechanism” located at the tip (see below) is now sealed, causing microscopic bacteria to get stuck in hard-to-access grooves and crevices. Per the FDA, this makes effective cleaning, disinfection and sterilization extremely difficult. As a result, CRE can be transmitted once the device is subsequently used on other patients.

Medical device infographic

It is critical for healthcare providers to strictly adhere to FDA, manufacturer, etc., requirements, perhaps go above and beyond, to ensure that medical devices are safe for use in patient procedures. As patients receiving treatment/services, we should ideally have peace of mind that the devices aren’t harmful and that our providers are taking the necessary care. It is also important we can be informed and feel comfortable communicating with our providers, whether asking questions or voicing any concerns we might have.

The FDA has now issued two Safety Communications that identify Olympus’ scope as well as scopes manufactured by other companies. The government agency urges all healthcare professionals and patients to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online:

Download the form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. If you were injured as a result of these endoscopes, please get in touch with our firm right away!