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Widow Sues Olympus and Custom Ultrasonics Over Husband's Superbug Death

Suit: Defectively designed duodenoscope made parts of the instrument difficult to access for cleaning and sterilization.

Published: November 23, 2015

— Willie Warner Jr., with his wife, Carla, died at age 55 in 2013.

Olympus America and endoscope reprocessor Custom Ultrasonics have been hit with a wrongful death and product liability lawsuit as a result of the 2013 "superbug"-related death of a 55-year-old North Carolina man.

Carla Warner, the widow of Willie Warner Jr., says her husband was exposed to Carbapenem-resistant Enterobacteriaceae (CRE) during a routine endoscopic retrograde cholangiopancreatography procedure (ERCP) at Carolinas Medical Center in Charlotte, North Carolina.

According to reports, the duodenoscope used on Mr. Warner was an Olympus TJF-Q180V that had been reprocessed in an AER manufactured by Custom Ultrasonics. Both the duodenoscope and the AER were later subjects of safety alerts from the FDA, which earlier this year warned that the design of duodenoscopes, including the Olympus 180, impedes effective cleaning, even when manufacturers' instructions are correctly followed. This month, the FDA issued another safety communication, stating that Custom Ultrasonics has continually failed to demonstrate that its AERs can adequately wash and disinfect endoscopes, and demanding that the company recall its AERs.

In the 8 months before her husband died, he "suffered horribly, enduring excruciating pain and losing 60 pounds" despite tube feedings, says Ms. Warner. He was repeatedly hospitalized, required external wound drainage, suffered delirium and oxygen deprivation, she says, and was kept away from friends and family due to concerns about the highly contagious infection. "I listened to him gasp for air as his O2 levels plummeted and heard him cry out, begging me not to leave his side due to the hallucinations he experienced in his delirium," she says.

The suit alleges that Mr. Warner would not have been infected had Olympus designed the scope to be safe, or warned hospital personnel that the device could not be adequately cleaned.

"Olympus leadership continues to prioritize the duodenoscope matter, says Mark A. Miller, the company's VP of corporate and medical communications. "We express our sympathy to those patients and to their families who have experienced or have been affected by these infections." The company, he says, is dedicated to doing its part "to eradicate the spread of harmful bacteria that threaten the success of life-saving endoscopy procedures."

Custom Ultrasonics did not respond to a request for comment.

Jim Burger


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