There have been two recent developments regarding the spread of CRE Superbugs via duodenoscopes used in ERCP procedures that the FDA warned about in February 2016.
In the first trial related to allegations of a contaminated duodenoscope, a Washington State jury found Olympus responsible for $6.6 million in damages and the hospital (Virginia Mason Medical Center) responsible for $1.1 million to the family of a patient that died in a deadly superbug outbreak. The jury concluded that the company failed to provide adequate warnings about the scope or instructions for its use after it was manufactured.
Fujifilm issued a voluntary recall of all of its ED-530XT duodenoscopes. The FDA has cleared an updated design and labeling for the Fujifilm duodenoscopes, and it is now replacing the forceps elevator mechanism including the O-ring seal, the distal end cap and providing new Operation Manuals. The new manual will instruct users of the ED-530XT duodenoscope to send the device away for annual inspection of the forceps elevator mechanism.
In January, Pentax warned customers that its ED-3490K video duodenoscope can develop cracks and gaps in the adhesive that seals the device’s distal cap to its distal tip, making it difficult to clean/disinfect. If customers do not remove duodenoscopes showing signs of physical damage, then it may increase the risk of infection transmission between patients.
The FDA has expressed concerns that Carbapenam-resistant Enterobacteriaceae (CRE) superbugs can spread between patients through the use of an infected duodenoscope. If you or a family member experiences a superbug infection following an ERCP (Endoscopic Retrograde Cholangio-Pancreatography) procedure, please call our office at 1-800-590-4116 to speak to an attorney about pursuing compensation for your injuries during a free initial consultation.