Updated to include information from Olympus.
The company said it won new 510(k) clearance for the TJF-Q180V model, for modifications to both the design and labeling of the device.
The redesigned endoscope from Olympus comes on the heels of a new report from the U.S. Senate’s health committee, which slapped blame on medical device companies and hospitals for deadly outbreaks of so-called “superbug” infections linked to the scopes.
Duodenoscopes are used for endoscopic retrograde cholangiopancreatography procedures, in which the tube-like camera instruments are inserted into the throats of patients for a variety of different treatments, such as draining fluids from pancreative and biliary ducts blocked by tumors or gallstones.
More than 500,000 such procedures are performed in the U.S. annually – but in February and March 2014, hospitals in Connecticut, Virginia, California and Washington state reported superbug outbreaks related to the devices and procedures.
“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,” CDRH chief scientist Dr. William Maisel said in an FDA press release.
The modified scope is redesigned with a tighter elevator channel sealing mechanism to reduce the potential for leakage of patient fluids and tissues into the closed channel.
Olympus said the corrective action will include updates to its operation and reprocessing manual for the devices. Included in the update is improved information on the use of Acecide-C high level disinfectant used to disinfect the duodenoscope, as well as updated annual inspection information, according to a press release.
The company said it plans to perform annual inspections of each scope in use to identify wear and tear on the channel sealing mechanism or attached debris to the tip, and repair or replace potentially contaminated parts.
Olympus said it is voluntarily recalling the original model to be modified and repaired as “quickly as possible.” The company expects it will be able to correct the mechanism in 4,400 models in use by August 2016.
The company will begin its recall and modification of devices in early February, according to a press release.