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Duodenoscope Infection Risk

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The US Food and Drug Administration (FDA) has issued a warning that duodenoscopes could be linked to the spread of deadly bacteria. This warning concerns ERCP endoscopes, also known as duodenoscopes, and comes on the heels of reports of serious multi-drug resistant bacteria in patients who had medical procedures involving the medical devices. Duodenoscope lawsuits have now been filed after patients reportedly developed infections linked to devices.


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Duodenoscope Super Bug

superbugpetridishOn February 19, 2015, the FDA warned that the complex design of ERCP endoscopes may prevent them from being properly sanitized, even when manufacturer recommended sanitation guidelines are followed.

"Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it," the FDA warned.

The agency noted that from January 2013 to December 2014 it received 75 medical device reports involving around 135 patients who suffered a possible microbial transmission from duodenoscopes. The FDA said it will continue to monitor the association between duodenoscopes and infectious agents.

One medical center linked to the outbreak is Ronald Reagan Medical Center at UCLA. The medical center said seven patients were infected by a bacteria linked to duodenoscopes. Two people reportedly died and 179 others may have been exposed, according to the Los Angeles Times (2/25/15).


duoendoscopeDuodenoscopes are lighted tubes inserted in a patient through the mouth to the top of the small intestine. They are used during endoscopic retrograde cholangiopancreatography (ERCP), a procedure involved in diagnosing and treating problems of the pancreas and bile ducts.

Because the duodenoscopes have many small parts, tissue or fluid from one patient can remain on a duodenoscope even after it is cleaned. This can result in a patient-to-patient infection. The FDA has said that the infections have occurred even after medical professionals followed proper manufacturer cleaning instructions.

Duodenoscope Lawsuits

An 18-year-old who developed a CRE (carbapenem-resistant Enterobacteriaceae) infection after undergoing a procedure involving a duodenoscope has filed a lawsuit against Olympus, maker of the device. According to the Los Angeles Times, although Olympus redesigned its duodenoscope it did not provide proper cleaning guidelines for the product.

Duodenoscope Infection Legal Help

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ED-530XT Duodenoscopes Recalled
ED-530XT Duodenoscopes Recalled
July 21, 2017
Santa Clara, CA: An urgent recall of all Fujifilm ED-530XT duodenoscopes has been issued, due to the difficulty in what the US Food and Drug Administration (FDA) refers to as “reprocessing.” Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. The voluntary recall of the duodenoscopes also includes replacement of the ED-530XT forceps elevator mechanism including the O-ring seal, replacement of the distal end cap, and new Operation Manuals. The FDA has previously issued a warning that duodenoscopes could be linked to the spread of deadly bacteria.

Older Model Duodenoscopes Pulled from Market
Older Model Duodenoscopes Pulled from Market
January 13, 2017
Santa Clara, CA: Fuji, the maker of allegedly defective duodenoscopes, has announced it plans to remove its legacy 250/450 duodenoscope models from clinical use. The decision is reportedly based on the limited number of duodenoscopes currently in use, not because of a known safety risk, and noted that it has not received any recent reports of adverse events associated with these scopes.

Olympus Failed to Warn US Hospital of Duodenoscope Infections
Olympus Failed to Warn US Hospital of Duodenoscope Infections
July 26, 2016
Santa Clara, CA: According to news reports from CNBC and the LA Times, contaminated Olympus duodenoscopes


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