Sen. Patty Murray, the top Democrat on the Senate health committee, sent a letter Monday to the president and CFO of Olympus demanding more information into a superbug outbreak at a foreign health facility linked to duodenoscopes recently redesigned to prevent infections.
Sen. Murray led a 2015 Senate investigation into infections caused by duodenoscopes which resulted in a 2016 recall agreement between Olympus and the Food and Drug Administration, in which Olympus asked organizations to return their TJF-Q180V duodenoscopes to the scope maker for a redesign.
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Now, she is looking for answers from Olympus in regards to the most recent outbreak, which affected five patients, one of whom has died.
"This tragic incident is particularly alarming because your company recalled and reportedly fixed the device in question after an investigation by my staff revealed a dangerous flaw in the design of Olympus duodenoscopes," Sen. Murray wrote. "I write to you today to request information in order to assess whether repaired Olympus closed-channel duodenoscopes are safe, and to understand whether the federal oversight of medical device safety in the United States is operating as it should."
She requested information be provided no later than April 17.