Duodenoscopes
Olympus Medical Systems Fined $80 Million
Olympus Medical Systems Corporation Failed to Report Adverse Events Leading to Settlements Olympus Medical Systems Corporations has entered a guilty plea after it was caught introducing devices into interstate commerce despite the fact that they were misbranded, and the company failed to file “Medical Device Reports” (MDR) after … [Read more...] about Olympus Medical Systems Fined $80 Million
FDA Cracking Down on Dirty Duodenoscopes
The federal government is cracking down on dirty duodenoscopes. In a publicly issued safety notice from the U.S. Food & Drug Administration, or FDA, the federal agency outlines some dangers of these reusable medical devices. Duodenoscopes are incredibly valuable medical devices, used in a common procedure to diagnose and … [Read more...] about FDA Cracking Down on Dirty Duodenoscopes
Endoscopic Retrograde Linked to Superbug Infections
Our firm is investigating potential lawsuits on behalf of patients who were infected with a multidrug-resistant bacteria, such as Carbapenem-Resistant Enterobacteriaceae (CRE), associated with the use of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes. These devices, which are inserted down a patient's throat … [Read more...] about Endoscopic Retrograde Linked to Superbug Infections
Medical Devices Safety Concerns
Medical Devices and its Safety Concerns Not Accurately Documented. Medical Device Safety Concerns.Every year, about 3,000 deaths in the United States are attributed to problems with medical devices, as reported by the Brookings Institute. Generally, medical devices and their safety issues are not as accurately documented as drugs, … [Read more...] about Medical Devices Safety Concerns
Olympus Fails to Warn Duodenoscopes Infection in Hospitals
Risk Of Infection with Duodenoscopes Still A Problem In The U.S. The duodenoscope debacle continues to grow, as an LA Times investigation reveals that scope maker Olympus failed to warn US hospitals about the risk of infection with its TJF-Q180V duodenoscope. According to LA Times, Olympus became aware of potential infections in … [Read more...] about Olympus Fails to Warn Duodenoscopes Infection in Hospitals
Heater-Cooler Systems Linked to Patient Infections
Patients May Have Been At Risk For A Type of Infection During Heart Surgery. WellSpan York Hospital in Pennsylvania notified 1,300 patients that they may have been at risk for a type of bacterial infection during heart surgery performed between October 1, 2011 and July 24, 2015. The potential infection stems from heater-cooler … [Read more...] about Heater-Cooler Systems Linked to Patient Infections
Lawsuit Filed Over Death of Patient Who Contracted Fatal Superbug
Patient Contracted Fatal Superbug Due To Pentax Scope. A wrongful death lawsuit has been filed in connection with the superbug outbreaks linked to contaminated duodenoscopes. The suit, which was filed on August 31, 2015 in state court in Cook County, Illinois, alleges that Pentax Medical, a division of Pentax of America, Inc. and … [Read more...] about Lawsuit Filed Over Death of Patient Who Contracted Fatal Superbug
Superbug Outbreaks Result in FDA Warning Letters
Duodenoscopes Have Been Linked To Outbreaks. A series of superbug outbreaks in hospitals across the country has resulted in FDA warning letters to Olympus Medical Systems, Pentax Medical, and Fujifilm from the Food and Drug Administration (FDA). In the letters, the FDA cited failure to report infections in a timely manner and … [Read more...] about Superbug Outbreaks Result in FDA Warning Letters
