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Outbreak Triggers Senator's Renewed Probe Of Olympus Duodenoscope

 
• By Sue Darcey

Prompted by reports from a European hospital of a microbial outbreak last year linked to an Olympus TJF-Q180V duodenoscope, causing one death and five infections, Sen. Patty Murray requested that the company send her "any and all reports" about the product's safety. The outbreak was not forwarded to FDA's adverse events database until early February.

Sen. Patty Murray, D-Wash., askedOlympus Corp. officials April 3 for copies of all adverse events related to two TJF-Q180V-model duodenoscopes, in response to an outbreak of Klebselia pneumonia linked to the scopes and one death reported at a foreign hospital last year. The death, which occurred at an unnamed European facility, was accompanied by similar infections in four other patients. It was not reported to FDA's adverse events database until Feb. 2.

Murray, who is ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, told Olympus in the April 3 letter she needs "to understand whether the federal oversight...

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