Wrongful Death Lawsuit Sparks Interest On Duodenoscope’s Bad Performance. The family of a man who died from an antibiotic-resistant bacterial infection following a routine medical procedure has filed a wrongful death lawsuit against Olympus America, Olympus Medical Systems Corp., and Custom Ultrasonics.
The lawsuit was filed on November 20, 2015, in United States District Court for the Eastern District of Pennsylvania.
The man had undergone endoscopic retrograde cholangiopancreatography (ERCP) at Carolinas Medical Center in Charlotte, North Carolina. During an ERCP, a medical dsevice known as a duodenoscope is inserted into the patient’s throat, and a small camera allows the doctor to visualize and sometimes treat certain problems of the biliary and pancreatic duct systems, such as gallstones.
The duodenoscope used in this procedure was an Olympus TJF – Q180V manufactured by Olympus America, Inc. and Olympus Medical Systems Corp, which is one of three manufacturers of most duodenoscopes used in the U.S.
According to the legal complaint, the duodenoscope used in the procedure was contaminated with a “superbug” known as carbapenem-resistant Enterobacteriaceae (CRE) and the device transmitted CRE to the patient, causing a virulent infection that eventually killed him.
The suit further alleges that the device’s design was defective and the death would not have happened if the device could have been adequately cleaned and disinfected.
FDA Issue Safety Warning About Automated Endoscope Reprocessor
The legal complaints states that the medical center cleaned its duodenoscopes, including the one used in the man’s procedure, with an automated endoscope reprocessor (AER), a cleaning device manufactured by Custom Ultrasonics, Inc., but the device did not adequately disinfect or sterilize the unit.
The widow alleges in the lawsuit that her husband, a truck driver, suffered from the CRE infection for over eight months before he died. He endured excruciating pain and repeated hospitalizations. He lost 60 pounds, required a feeding tube, required external wound drainage, and suffered delirium and oxygen deprivation.
He became unable to perform any routine tasks for himself. Because CRE is highly infectious, the man was isolated from friends and family during most of his illness.
Since the man’s death, both the endoscope and the AER cleaning device were the subject of safety alerts from the U.S. Food and Drug Administration. On February 19, 2015, the FDA issued a safety communication warning that the design of ERCP endoscopes, including the Olympus 180, impedes effective cleaning, and that multi-drug-resistant bacteria may be transmitted by an endoscope even when the manufacturer’s cleaning instructions are correctly followed.
On November 13, 2015, the FDA issued another safety communication finding that Custom Ultrasonics had “not demonstrated that its AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection.” The FDA has directed Custom Ultrasonics to recall its AERs and recommends that health care facilities find alternative cleaning methods.
Contaminated endoscopes have been linked to a number of CRE outbreaks. Seven patients at Ronald Reagan UCLA Medical Center contracted an antibiotic-resistant strain of bacteria after undergoing endoscopic procedures with a device made by Olympus Corp. Two of the patients died from the infection. Earlier this year, Cedars-Sinai Medical Center in Los Angeles reported that four patients were infected with the same superbug after being treated with the same endoscope. Reuters has reported that infections following endoscopy have occurred in Seattle, Pittsburgh, and Chicago.