This report is being supplemented to provided additional information based on the legal manufacturer¿s final investigation.Based on the legal manufacturer¿s investigation, the dhr was reviewed and there were no problems found during the manufacturing of the device.The device met all specifications at the time of shipment.The failure to replace the expired acecide reprocessing solution is due to user error.As stated in the reprocessing manual instructions for use: "use a disinfectant cleared/approved by your national regulatory agency for use in reprocessing flexible endoscopes.If national or professional guidelines applicable to your institution define ¿high-level disinfection¿ and require using a high-level disinfectant for the flexible endoscopes, follow the requirement.Follow the disinfectant manufacturer¿s instructions regarding activation (if required), concentration, temperature, contact time, and expiration date." h3 other text : the device was not returned to olympus.
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