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FDA validates new reprocessing protocol for Olympus endoscope

New sterilizing technique approved after deadly UCLA superbug outbreak kills two

The Food and Drug Administration (FDA) recently approved a new reprocessing protocol for disinfecting the Olympus TJF-180QV duodenoscope, which is a type of endoscope.  Healthcare workers are advised to immediately implement the new disinfecting protocols, train staff on the procedures, and report any adverse events associated with the duodenoscope.

The TJF-180QV duodenoscope is linked to the “superbug” outbreak at UCLA Ronald Reagan Medical Center in early 2015 which killed two and exposed almost 180 others to an antibiotic resistant bacteria called carbapenem-resistant enterobacteriaceae.  Patients at UCLA Medical Center were exposed to the superbug bacteria after undergoing medical procedures with improperly disinfected Olympus TJF-180QV duodenoscopes.  Olympus faces several endoscope infection lawsuits due to injuries and deaths associated with with its TJF-180QV duodenoscope.

What is a duodenoscope?

Duodenoscopes are a type of endoscope.  Duodenoscopes are flexible tubes with lights and a mechanism at the end of the device.  They are commonly used in endoscopic retrograde cholangiopancreatography (ERCP).  An ERCP is a minimally invasive procedure which involves inserting the flexible duodenoscope down a patient’s throat to drain fluids from pancreatic and biliary ducts. Fluids can build up in a patient’s digestive tract because of gallstones and certain cancers.  Approximately 500,000 ERCPs are performed annually in the United States.

The Olympus TJF-180QV duodenoscope has moving parts at the end of the flexible scope which can be difficult to reprocess if proper procedures are not followed.  Bacteria from bodily fluids and organic debris left over from previous procedures can build up the crevices of the device, potentially exposing patients to aggressive strains of antibiotic resistant bacteria.  If these bacterias reach a patient’s bloodstream, the mortality rate can be as high as 50%.

Olympus marketed duodenoscopes without FDA approved cleaning procedure

The TJF-180QV was a new version of the 180 series duodenoscopes sold by Olympus without an FDA approved reprocessing protocol.  In 2013, dozens of other patients were exposed to a superbug bacteria in a similar outbreak at Virginia Mason medical center in Seattle, WA.

In February 2015, the FDA issued a safety communication to hospitals using duodenoscopes warning healthcare providers to take care when reprocessing the device.  The safety communication also advised doctors to inform patients of the risk associated with undergoing procedures involving duodenoscopes and the symptoms associated with possible bacterial infections.

Olympus endoscope lawsuits

Olympus America Inc. faces several lawsuits associated with its TJF-180QV duodenoscope.  Families of deceased patients who contracted severe bacterial infections after undergoing ERCPs allege negligence on the part of Olympus for marketing the duodenoscope without properly testing, marketing, or manufacturing the device.

Plaintiffs allege fraud on the part of Olympus America Inc. for intentionally misrepresenting the TJF-18-QV’s cleaning protocols and failing to disclose the device did not have an FDA approved cleaning procedure.  Plaintiffs allege Olympus knew or should have known of the difficulty in cleaning of duodenoscopes because of the moving parts built into the end of the scope. The Cochran Firm, D.C. is closely monitoring the situation with Olympus endoscope bacterial infections and offers free case consultations to individuals (or their family members) who have suffered serious injuries caused by these endoscopes. Because we represent clients on a contingency basis, there are no legal fees until you win your claim.


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