A wrongful death lawsuit against Olympus America, Olympus Medical Systems Corp. and Custom Ultrasonics has been filed over the use of an allegedly contaminated medical scope. The suit was filed on behalf of a woman whose husband died of an antibiotic-resistant infection after undergoing a routine Endoscopic Retrograde Cholangiopancreatography (ERCP) with a duodenoscope, a device that is snaked down a patient’s throat to visualize and treat problems in the biliary and pancreatic duct systems.
Duodenoscopes came under increased scrutiny after being linked to outbreaks of “superbugs”, bacterial infections that cannot be adequately treated with antibiotics. In February, the U.S. Food and Drug Administration (FDA) warned that the complex design of duodenoscopes may impede effective cleaning; the agency cautioned that the devices may transit multi-drug-resistant bacteria even when cleaned according to manufacturer’s instructions. The FDA issued another safety alert in November stating that Custom Ultrasonic had “not demonstrated that its AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection.” The company has been instructed to recall its automated endoscopes reprocessors (AER). Facilities who use Custom Ultrasonics AERs were urged to use different methods for cleaning the scopes.
According to the lawsuit, the duodenoscope used on the plaintiff’s husband was the Olympus TJF – Q180V, also referred to as the “Olympus 180”. The suit alleged that the scope is to blame for the Carbapenem-resistant Enterobacteriaceae (CRE) infection that killed him. Olympus is accused of failing to warn that the device cannot be sufficiently cleaned. The lawsuit also alleges that Olympus failed to design the scope safely.
The plaintiff’s husband suffered from his CRE infection for eight months before dying, the lawsuit states. The suit alleges he suffered from excruciating pain, delirium and oxygen deprivation; he lost 60 pounds and had to be hospitalized numerous times. He also needed a feeding tube and external wound drainage. According to the complaint, he had to endure the suffering without the comfort of his loved ones due to the contagious nature of his illness.