Three Japanese companies known more for their cameras than medical devices have been called on the U.S. FDA carpet to explain why their medical scopes may be associated with at least two "superbug" deaths.
The duodenoscope safety saga is growing ever more dramatic. The infected endoscopes for visualization of the bile and pancreatic duct have left dead patients in their wake, since at least 1987, it turns out. Are duodenoscopes this year's equivalent of power morcellators? Attorney Peter Kaufman plans four to six additional lawsuits against duodenoscope manufacturer Olympus, including three wrongful death suits related to an outbreak of the antibiotic-resistant "superbug" known as CRE.
Less than a week after the FDA warned healthcare providers that endoscopes' design could make them more difficult to clean, contributing to the spread of drug-resistant bacteria, Olympus is facing the first patient suit over the devices stemming from a "superbug" outbreak at the UCLA Health System in California.
The U.S. Food and Drug Administration is working to update the labels for duodenoscopes linked to the recent "superbug" outbreak that were inadequately cleaned, according to a Reuters report.
The FDA has warned that even if healthcare providers clean endoscopes according to manufacturer recommendations, a risk of infection still remains.
In the latest incidence of the outbreak of infections stemming from unclean endoscopes, 8 patients in Philadelphia were recently infected with bacteria resistant to the antibiotics known as carbapenems, which kill up to half of those infected, the Philadelphia Inquirer reports.
The U.S. Department of Justice is investigating allegations that Olympus representatives may have violated a pair of federal laws governing kickbacks and false claims in marketing its medical devices, the Japan-based company said.
Olympus, still in recovery mode after revealing a massive accounting scandal in 2011, continues attempts to refocus investor attention with the launch of new products. This time, the Japanese maker of endoscopes and cameras is rolling out a new tool designed to help speed up minimally invasive sinus surgeries.
A San Francisco startup is plowing ahead developing a low-cost endoscopic device at a fraction of the price of products currently on the market. Such an advance could give Olympus and other competitors a run for their money, but the company's co-founder insists he'll pitch it in emerging markets.
Nikon, the Japanese camera and technology giant, is exploring a plunge into the medical device business.