Medical device manufacturer Olympus Corp. recently announced it will be voluntarily recalling their defective duodenoscopes, which have been tied to the spread of serious infections in hospitals across the country. The company came under fire after an investigation revealed they knew about the problem for years, but failed to report it.
Over 140 people have reported serious infections related to the device in the U.S. and 21 people have died.
The devices are similar to endoscopes, used to inspect the gastrointestinal tract for signs of cancer, gallstones or other problems. A small camera sits at the end of a flexible tube that can be threaded into the digestive tract from the patient’s mouth.
The TJF-Q180V model was designed to make cleaning the device quicker by sealing the camera in a water-tight casing. However, a defective rubber ring in the assembly allowed bodily fluids to seep through tiny cracks. Cleaning the device, even with specialized equipment, failed to remove the contamination.
Since the devices are re-used on other patients, anyone who was examined with the device could have been exposed to infectious bacteria and viruses.
Olympus Knew About the Problem
An outbreak in the Netherlands led to in an investigation in 2012, when the issue was discovered. However, Olympus continued to sell the product in the U.S. without warning.
When problems were reported by hospitals, Olympus representatives told them the problems were due to improper cleaning, rather than a design flaw. They also failed to report the problem to the FDA and failed to inform hospitals that outbreaks had occurred in other locations.
U.S. Senate Investigation
The U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee recently released a 301-page report on the infection risk associated with duodenoscopes from several manufacturers including Olympus, Pentax and Fujifilm. They cited the companies’ failure to meet regulatory obligations, failure to seek proper Food and Drug Administration clearance, inadequate testing, and lack of transparency.
They also detailed problems with the FDA’s flawed reporting system, which made it difficult to track problems and identify an issue before it became too big. The FDA’s approval process has come under fire from several healthcare advocates, related to the Essure birth control device and transvaginal mesh makers, among others.
After getting a re-designed scope approved by the FDA in January, Olympus issued the voluntary recall for the TJF-Q180V and will be replacing the defective component.
If you or a loved one has suffered a severe infection after being examined with an Olympus medical scope, please contact the defective medical device lawyers at D’Amico & Pettinicchi today.