The senior supply coordinator for central sterile processing (csp) department at the facility reported the scope was not used on patients after it was broken and there were no patient infections as a result of the event.Additionally, the ear nose & throat operating room (or) coordinator reported that if the cap was not placed on the scope for processing it was disinfected properly according to csp standards.Once it was done being used in the or, it was flushed at the end of the cases with sterile water and wiped with a wet 4x4.Then it was sent to csp for further cleaning.
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This supplemental report was submitted to provide additional information to mdr# 8010047-2020-2232.The original equipment manufacturer (oem), omsc, performed a device history record review and no abnormalities were noted.No device was returned to the oem, however, an investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.Based on the information provided, the potential root cause has been determined to be incorrect gas sterilization, reprocessed without using eto cap.The bending section cover may have ruptured by the difference of air pressure between inside and outside of the scope while sterilized by gas.The instructions for use (ifu) instructs to attach the eto cap when conducting gas sterilization.The event was preventable by conducting reprocessing in accordance with ifu.The product¿s ifu (operation manual) describes the following: "6.5 eto gas sterilization" attach the eto cap to the endoscope connector before sterilizing.If the eto cap is not attached on the endoscope during sterilization, the vacuum created within the sterilization chamber can rupture the covering of the bending section."inspection of the endoscope" visually inspect the external surface of the entire insertion tube for dents, bulges, swelling, peeling or other irregularities.Holding the insertion tube gently with a hand carefully run your fingertips over the entire length of the insertion tube in both directions (see figure confirm that there is no object stopping the hand or protruding objects or other irregularities.
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