According to the U.S. Food and Drug Administration (FDA), Pentax has reported that its ERCP duodenoscope has design flaws that could increase the risk to patients of contracting a bacterial infection.
Pentax had updated its duodenoscope cleaning instructions in February 2016 following an FDA Safety Communication that linked the medical devices to bacterial infections. This is because the design of the ERCP (endoscopic retrograde cholangiopancreatographic) duodenoscope can allow bacteria to form in places where parts of the device connect following cleaning.
After the cleaning instruction update in 2016, Pentax again alerted the FDA that cracks could occur in an adhesive that seals the scope’s distal cap to the distal tip, leading to the formation of bacteria. The problem affects the company’s model ED-3490TK duodenoscopes.
Duodenoscopes are used in approximately 700,000 ERCP procedures annually. The scopes are attached to tiny cameras that allow doctors to perform minimally invasive surgeries and diagnostic tests on the small intestine (duodenum), pancreas, bile duct and gall bladder. ERCP procedures are routinely used to diagnose or treat:
- Choledocholithiasis, or gallstones
- Acute pancreatitis, or sudden inflammation of the pancreas
- Chronic pancreatitis, or long-term inflammation of the pancreas
- Pancreatic divisum, when the pancreatic duct exists as two ducts rather than one
- Pancreatic or biliary cancer
In recent years, duodenoscopes have been linked to the spread of antibiotic-resistant infections that have high mortality rates. In January 2015, UCLA Medical Center suffered a “superbug” outbreak linked to duodenoscopes. The outbreak killed several patients and injured more than 200 others. The incident led to a recall by Olympus, the manufacturer of the scopes tied to the outbreak, as well as a number of personal injury lawsuits against the company.
Last year, Fujifilm pulled four of its duodenoscope models from the market and replaced them with newer models.
If you have suffered injuries from an unsafe or defective medical product, the experienced product liability legal team at Roberts & Roberts is here to help with compassionate, aggressive representation. Please call 800-248-6000 or contact us for a free consultation.