This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record confirmed the subject device was shipped in accordance to specifications.Based on the results of the investigation, the operator did not conduct the proper reprocessing procedure.The instructions for use identifies information regarding the suggested event within "chapter 3 inspection before use": 3.10 checking the disinfectant solution concentration level: prior to reprocessing, check the concentration of the disinfectant solution using a test strip to verify that the concentration of disinfectant solution meets the minimum recommended concentration.Replace the disinfectant solution when it fails to meet minimum recommended concentration or beyond the specified use life.Information was received from the customer via email on 19jan2021 with the following information: they were last provided a reprocessing in-service on 09dec2020, there has been no change in personnel since then and all personnel have been trained on how to properly reprocess an endoscope.They also confirmed that there were no patient infections or scopes with positive cultures.
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