Tagged Articles

Olympus’ TJF-Q180V duodenoscope 3 articles

Olympus, hospital played role in spread of deadly infection

A Washington state jury slapped medical device maker Olympus Corp. with a near-$6.6 million in damages for not adequately instructing a Seattle hospital on how to properly clean and disinfect its specialized endoscope. However, the jury did not find that Olympus’ duodenoscope caused a patient’s fatal infection in 2013, Law360 reported. Jurors found that patient Richard Bigler’s infection which led to his 2013 death was caused by Virginia Mason Medical Center’s negligence in its use of the Olympus TJF-Q180v duodenoscope. The hospital was ordered to pay $1 million in damages to Bigler’s family. Jurors also determined that the device was ... Read More

FDA approves new cleaning instructions for Olympus duodenoscopes

Validated manual reprocessing instructions for two models of Olympus Corporation of the Americas duodenoscopes have been updated to replace those provided in the original device labeling, the Food and Drug Administration (FDA) announced in a Safety Alert. The instructions, which cover both the TJF-160F and the TJF-160VF duodenoscope models, have been reviewed by the FDA and found to meet the agency’s expectations. Duodenoscopes are specialized endoscopes that are fed down patients’ throats to diagnose and treat conditions affecting the pancreas and bile duct. The devices have been linked to outbreaks of drug-resistant bacterial infection at hospitals across the country. In ... Read More

FDA updates safety communication about Olympus duodenoscopes

The Food and Drug Administration (FDA) is issuing an update to a March 26, 2015, Safety Communication regarding one of Olympus Corporation’s duodenoscopes. The specialized endoscopes have come under scrutiny in recent months when they were linked to the spread of drug-resistant superbugs at more than a dozen hospitals across the country. Duodenoscopes are surgical tools that are fed down patients’ throats in order to diagnose or treat conditions affecting the pancreas and bile duct. Researchers found that small crevasses in the scope could harbor bacteria even after the devices have been cleaned and disinfected. The bacteria can then be ... Read More