The FDA reported five patients from an overseas hospital tested positive for Klebsiella pneumoniae after providers treated them with the Tokyo-based Olympus TJF-Q180V duodenoscope, Los Angeles Times reports.
Here’s what you should know.
1. Olympus voluntarily recalled the devices in January 2016 to replace a mechanism linked to deadly outbreaks around the world. The unspecified hospital replaced their duodenoscopes in October 2016, according to the FDA.
2. It was unclear from the report if the hospital properly disinfected the devices following Olympus’ new recommendations.
3. An FDA spokesperson said to the Times, “[The FDA] was aware of these reports and continues to investigate adverse events associated with duodenoscopes as appropriate.”
Olympus spokesperson said Olympus notified the FDA of the reported event and said to the Times, “In the interest of patient safety, it is premature to reach a conclusion regarding the cause.”
4. The FDA linked the scopes to several superbug outbreaks in Southern California in 2015 where 30 patients died.
5. Several reports claim Olympus knew the scopes original flaws in 2012. They didn’t alert American hospitals or regulators until February 2015 after the California outbreaks, the Times reports.
6. American hospitals still use approximately 4,400 of the Olympus devices.
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