(Reuters) – An unnamed hospital in Oklahoma used contaminated gastroscopes in procedures performed on nearly a thousand patients in recent months, device maker Pentax Medical told U.S. regulators last month, putting the patients at risk of exposure to bacteria that can cause infections.
In a July 22 report here that only recently became public and was reviewed by Reuters, Pentax told the Food and Drug Administration that a hospital used up to four gastroscopes contaminated with bacteria in 998 procedures performed sometime last year through June 2019, when the problem was discovered. Pentax, a unit of Tokyo-based Hoya Corp, said it was not aware of any patient infections thus far.
Gastroscopes are inserted in the mouth and used to examine the stomach, conduct biopsies and perform other procedures.
The FDA redacts the names of hospitals from device injury reports before releasing them publicly. “Per FDA regulation, we are not permitted to disclose the facility identity…
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