Medical Device Company Gets Okay for Redesign of Defective Duodenoscope
March 16, 2016 | By admin
Olympus, a major manufacturer and distributor of medical devices, recently received approval from the U.S. Food and Drug Administration (FDA) of a redesigned duodenoscope. The redesign came in response to a product recall after reports of numerous infection incidents involving a previous version of the medical device that was considered defective.
What is a Duodenoscope?
A duodenoscope is a device that is inserted down the throat during an invasive medical procedure known as endoscopic retrograde cholangiopancreatography (ERCP). Every year, doctors perform 500,000 ECRPs in the United States. The procedure allows surgeons to drain fluids from the pancreatic and biliary ducts, something that is not easy to do when the ducts are blocked by cancerous tumors or gallstones.
The problem with using duodenoscopes is that they can pose significant health problems to patients. The medical devices are difficult to clean and disinfect, occasionally resulting in serious bacterial infections that can linger and, in the worst cases, lead to death.
FDA Requires Redesign of Olympus Duodenoscope due to Safety Concerns
At the beginning of 2016, Olympus issued a product recall of the company’s TJF-Q180V model duodenoscope. This particular model was used in approximately 4,400 healthcare facilities and hospitals across the U.S., including New Jersey, New York and Pennsylvania.
The recall was necessitated by a rash of infections involving duodenoscopes manufactured by Olympus and other medical-device providers. According to health officials who reported to a U.S. Senate committee, these duodenoscopes were linked to at least 25 serious infection incidents since 2012. It is believed that the cause of the infections may have been a product defect that caused leaking during use.
Now the FDA has signed off on Olympus’ newly designed medical device. The hope is that the redesigned duodenoscope will reduce the risk of contamination and infections in ECRP patients.
For additional information about this product recall and subsequent redesign, read the ModernHealthcare.com article, “Olympus to Begin Voluntary Recall of Its Duodenoscopes.”
If you or a loved one has suffered an injury due to a defective product, it is imperative that you speak with a qualified personal injury and product liability attorney. The experienced product liability lawyers at Lombardi & Lombardi can help you explore all of your legal options and seek the compensation you need, want and deserve. Contact us now to schedule a free consultation at one of our offices in Edison, Brick or Freehold, NJ.