Olympus recalls thousands of surgical scopes linked to infections
Thousands of surgical scopes have been recalled by Olympus, a medical device manufacturer, as they have been linked to deadly infections according to The Marshalltown
In the past three years, at least 250 patients in the US and Europe have been infected, some of whom have died, after undergoing procedures in which a scope called a duodenoscope was used to identify and treat conditions of the pancreas and bile duct according to the news site.
Olympus is now voluntarily recalling the original model of its duodenoscope TJF-Q180V as the US Food and Drug Administation (FDA) have cleared a newer model of the device which has modifications to the design and labeling intended to help reduce the risk of bacterial infections.
In the newer model of its duodenoscope Olympus modified its design of the elevator channel sealing mechanism to create a tighter seal and reduce the potential for leakage of patient fluids and tissue into the closed elevator channel.
The company also plans to conduct annual inspections of each scope in use by facilities to identify any wear and tear on the elevator channel sealing mechanism or the presence of attached debris at the scope’s tip, which would require replacement of the potentially contaminated parts.
William Maisel, deputy director for science and chief scientist in the FDA’s center for devices and radiological health, said: “We have made it a top priority to improve the safety of duodenoscopes and help protect patients from bacterial infections associated with these medical devices.
“The Olympus TJF-Q180V’s new design, as well as the new annual inspection program, is intended to reduce the risk of fluid leakage into the elevator channel, which in turn can reduce patient exposure to bacteria and other potential infections.”
Olympus plans to contact each facility that owns a TJF-Q180V duodenoscope and will provide instructions on returning the original TJF-Q180V for a replacement that Olympus will provide free of charge.