Evis Exera III Video System - Gastrointestinal Videoscope

The GIF-1TH190 reprocessing manual has instructions for either High Level Disinfection (HLD) reprocessing or Ethylene Oxide Gas (EOG) sterilization after endoscope cleaning. As a result of testing, Olympus discovered EOG sterilization failures in which the GIF-1TH190 failed to achieve sterilization following the GIF-1TH190's reprocessing manual. As a result of the subsequent investigation, Olympus determined that changes are required to the endoscope's channel drying steps following cleaning and prior to EOG sterilization in order to ensure effective endoscope sterilization. Accordingly, Olympus has updated the instructions for the endoscope channel's drying process and validated that the new, updated channel drying steps will result in GIF-1TH190 endoscope EOG sterilization. The revised instructions for the "dry the endoscope" in chapter 5.7 of the GIF-1TH190 reprocessing manual are provided in a supplied addendum.

Recall start date: October 11, 2023