On August 30. 2019 and unnamed hospital in Oklahoma used contaminated gastroscopes in procedures performed on nearly one-thousand patients in recent months. The device maker, Pentax Medical told U.S. regulators last month putting the patients at risk f exposure to bacteria that can cause infections.
In a July 22 report that only recently became public, 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. Gastroscopes, like other endoscopes, are brushed and washed with disinfectants in preparation for the next patient. Despite those efforts, contamination can persist and patients can be exposed to drug-resistant bacteria and develop infections that are difficult or even impossible to treat.
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 publicly.”
Neither Pentax nor the Oklahoma State Department of Health would name the hospital involved.
According to Pentax, the incidents described were a “failure by the facility reprocessing personnel to completely follow” the company´s cleaning instructions for gastroscopes.
The company said the “hospital has notified all potentially affected patients of their options for post-exposure medical screening.”
Gastroscopes, like other endoscopes, are brushed and washed with disinfectants in preparation for the next patient. Despite those efforts, contamination can persist and patients can be exposed to drug-resistant bacteria and develop infections that are difficult or even impossible to treat.
If you ar a loved one has been contacted by an Oklahoma hospital concerning possible infection due to the use of a Pentax Medical gastroscope, contact the Offices of Jones Brown Law today.
Jones Brown Law
If you or a loved one have suffered complications from a Pentax Medical gastroscope, contact our offices immediately. The Jones Brown Law team has experience helping countless victims of defective drugs and devices, and we are currently accepting clients who have suffered infections caused by the Pentax Medical gastroscope. At Jones Brown, we’ve made it our mission to provide legal representation of the highest caliber at a rate that is affordable to everyone. Our goal is to make legal representation and services attainable for all those who seek it, without the need to compromise ethics, experience, or quality of service. All of our attorneys adhere to a strict code of professional ethics, upholding our Client Bill of Rights, to ensure that our clients are treated with the respect and attention they deserve.