Makers of duodenoscope and reprocessor face wrongful death lawsuit

Accreditation Insider, December 1, 2015

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A wrongful death lawsuit was filed last month against the makers of a duodenoscope and reprocessor after a patient in a North Carolina was infected and died following an endoscopic procedure.
In 2013, Willie Warner Jr. received a routine endoscopic retrograde cholangiopancreatography (ERCP) procedure at Carolinas Medical Center in Charlotte, N.C., according to a press release issued by the law firm Lieff Cabraser Heimann & Bernstein. During the ERCP, a duodenoscope was put into his throat to look for problems with his biliary and pancreatic duct systems. The lawsuit alleges that the duodenoscope infected Warner with Carbapenem-resistant Enterobacteriaceae (CRE), resulting in his death eight months later.
On November 20, Warner’s widow filed a wrongful death suit against both Olympus America and Custom Ultrasonics. Olympus America were the makers of the duodenoscope used during Warner’s procedure and Custom Ultrasonics made the automated endoscope reprocessor (AER) used to sterilize it. The suit claims the Olympus America didn’t warn hospital personnel that the design the Olympus 180 duodenoscope prevented it from being adequately cleaned. It also claims that the Custom Ultrasonics AER didn’t disinfect the device correctly before it was used.
The lawsuit comes in the wake of two major FDA decisions regarding the Olympus America and Custom Ultrasonic. In April, the FDA ruled that the basic design of ERCP endoscopes prevents them from being cleaned properly, and warned that duodenoscopes such as the Olympus 180 were unable to be properly cleaned even if instructions were followed. In November, the FDA issued a recall of all Custom Ultrasonic AERs, claiming the company couldn’t prove their products could properly disinfect endoscopes.

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