Olympus revealed updated cleaning instructions for duodenoscopes linked to a recent superbug outbreak at UCLA, weeks after the FDA warned that the devices' complex design may contribute to the spread of deadly bacteria and called for label modifications.
Rep. Ted Lieu (D-CA) is calling for a federal investigation into the duodenoscope safety scare that has claimed lives and spread the dangerous pathogen CRE to patients across the nation. And he just sent a letter to Olympus asking the company why it did not seek FDA clearance for a 2010 redesign of its duodenoscope, if it plans to redesign the device in the future, and when the company first learned of the risk posed by the device.
Olympus Medical Systems has received its fifth suit filed by a patient claiming to have been infected with the hospital "superbug" as a result of inadequate sterilization of its duodenoscope.
Olympus was slapped with two new lawsuits over endoscope devices tied to a recent superbug outbreak at UCLA, adding to a mounting heap of litigation from patients and families affected by the devices.
A review of Olympus presentations to the U.S. FDA over its duodenoscopes suggests the Japan-based medical-device maker may have been "hoist with his own petard" in its attempt to have cleaning guidelines watered down.
Olympus is facing more pushback over endoscopes tied to drug-resistant superbug outbreaks at U.S. hospitals, as new reports show the company asked the FDA to soften its guidelines on cleaning procedures for the products.
One of the three Japan-made endoscopes associated with recent superbug outbreaks--the duodenoscope made by Olympus--did not have FDA approval, CNN reports.
Amid growing pushback from lawmakers and patient groups over endoscopes linked to deadly bacterial infections, a new drug-resistant superbug outbreak related to the devices has cropped up at a second Los Angeles-based medical center.
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.