The three manufacturers that market duodenoscopes in the U.S. have all been required by the FDA to submit postmarket surveillance plans to the agency within 30 days. This comes after all three received warning letters from the agency in August and an FDA committee panel took up the same issue in May.
Japan's Sony announced that what it claims is a revolutionary ultrahigh-definition endoscope system, developed since 2013 with Olympus, will reach markets in Japan and Europe next month.
Olympus and Sony are rolling out a high-definition endoscope, months after Sony--Olympus' largest shareholder--announced that it would sell off half its stake in the company amid growing scrutiny over Olympus' duodenoscope devices.
Olympus was slapped with another lawsuit over devices implicated in a superbug outbreak at UCLA Medical Center, adding to the company's mounting heap of litigation as it faces pushback from affected patients and families.
Two more Japanese manufacturers of specialized medical scopes linked to a "superbug" outbreak were subpoenaed by the U.S. Department of Justice (DOJ) this week, reports said, as Olympus already faces related regulatory scrutiny and lawsuits.
As the FDA gears up for a panel meeting regarding duodenoscope devices linked to deadly bacterial infections, a U.S. hospital is joining forces with a patient's family to sue the largest manufacturer of the product.
The Olympus problem with one of its duodenoscopes has cropped up again with another major suit in the United States and new assertions the device also was linked to hospital superbugs in Europe.
Olympus is plowing ahead on its medical device strategy, opening a new surgical innovation center in Brooklyn Park, MN. The move comes despite the company's recent problems with difficult-to-clean duodenoscopes that are resulting in the spread of antibiotic-resistant bacteria that can cause disease and even death among some patients.
As Olympus faces mounting backlash for endoscope devices linked to the recent superbug outbreaks, Sony, the company's largest shareholder, is selling off half its stake to raise funds for strategic investments.
Olympus will pay as much as 11 billion yen ($92 million) to settle two lawsuits based in a 2011 accounting scandal. This comes just as the camera and medical imaging company has been identified as one of several companies whose dirty duodenoscopes have infected some patients with antibiotic-resistant bacteria.