Duodenoscope Infection Legal News Articles & Interviews

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.

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.

Santa Clara, CA: According to news reports from CNBC and the LA Times, contaminated Olympus duodenoscopes

Santa Clara, CA: A US Senate investigation has found that scores of patients who received medical care involving duodenoscopes were needlessly infected with potentially deadly bacteria. According to a report by the LA Times, the investigation revealed 25 outbreaks, two in Los Angeles, directly linked to the medical device. The investigators cited repeated failures by the makers of duodenoscopes, regulators and hospitals to report outbreaks.

Washington, DC: Duodenoscope infection: It’s a perfect storm and a Catch 22 of sorts for any patient in need of endoscopic retrograde cholangiopancreatography procedures (ERCP). The use of a duodenosope, a lighted and flexible tube used to drain fluids from blocked pancreatic and biliary ducts, can be life-saving for the patient.

Washington, DC The U.S. Food and Drug Administration (FDA) has ordered the three manufacturers of duodenoscopes marketed in the US.. to conduct postmarket surveillance studies to better understand how the devices are reprocessed in real-world settings.

Las Vegas, NV In February 2015, officials at UCLA Ronald Reagan Medical Center reported that seven patients at the hospital were infected and two died after being infected with a deadly superbug embedded in a type of medical device known as a duodenoscope (or ERCP endoscope) used to investigate patients with gastrointestinal complaints.

Los Angeles, CA A recent outbreak of carbapenem-resistant Enterobacteriaceae (CRE) bacteria at Ronald Reagan UCLA Medical Center in Los Angeles has been linked to contaminated duodenoscope. At least two people are dead, and officials have said dozens of other patients may have been exposed to the potentially fatal bacteria. Additionally, Cedars-Sinai Medical Center, also in Los Angeles, has reported four patients this year who became infected with the superbug following procedures involving duodenoscopes.

Los Angeles, CA Two people are dead and 179 potentially infected with a deadly superbug found at a UCLA medical center. According to a report by Frontline, the antibiotic resistant superbug outbreak took place at Ronald Reagan Medical Center from October 2014 to January 2015.