Olympus Issues Recall for Unsafe Duodenoscope Devices
Olympus Corporation has issued a voluntary recall for the TJF-Q180V duodenoscope device. Duodenoscopes are used in more than 500,000 gastrointestinal endoscopic procedures each year. These devices are used during endoscopic retrograde cholangiopancreatography (ERCP) procedures to diagnose and treat conditions within the bile duct and main pancreatic duct, such as gallstones and cancer. The duodenoscope can be used to drain fluid from bilary and pancreatic ducts that are blocked by tumors, gallstones or other conditions affecting the gastrointestinal system.
However, there is evidence that the devices may have contributed to the transmission of Carbapenem-resistant enterobacteriaceae (CRE), forms of antibiotic resistant infections and other infectious material.
A United States Senate investigation attributed 25 outbreaks of antibiotic resistant infections, in the United States and Europe, to cross-contamination by improperly sterilized duodenoscopes. The infections were identified in nearly 250 patients, though many additional cases may not have been reported. More than 10 cases of such infections resulted in patient fatalities.
The report identifies that duodenoscope manufacturers, such as Olympus, failed to inform hospitals and physicians of design flaws that prevent duodenoscopes from being properly decontaminated between patient use. The investigation also criticized hospitals and government regulatory agencies for failing to report incidents of infection.
Olympus—the manufacturer and supplier of approximately 85% of the scopes used in United States hospitals—was specifically cited for its negligence in warning hospitals of the cross-contamination hazards. Manufacturers may have been aware of device flaws as early as 2012.
On January 15th, 2016, the Food and Drug Administration (FDA) approved design modifications made to the Olympus TJF-Q180V duodenoscope. The alterations in the device’s design and labeling are intended to reduce the risk of bacterial infection and cross-contamination. Olympus has also indicated that it plans to conduct annual inspections of each device, in order to identify any wear on the re-designed sealing mechanism or the presence of attached debris at the scope’s tip—flaws that may require replacement of the parts.
Lawsuits are now being filed by patients, and their families, who contracted CRE and other antibiotic resistant infections. Some of these lawsuits stem from an infection outbreak at UCLA in 2015 affected seven patients, killing two of them. Nearly 180 other patients may have been exposed to CRE during this time.
If you or a loved one suffered from severe abdominal pain, gallstones, pancreatic cancer, or bilary or pancreatic duct obstructions between 2012 and 2015, and underwent a procedure using a duodenoscope, you may be able to seek legal redress. Contact the attorneys at the Law Offices of Peter Angelos, P.C., for a no-cost legal consultation.