The scope was not returned for evaluation.The gi manager provided information regarding the reprocessing.Pre-cleaning is being performed immediately after a procedure as per manufacturer's pre-cleaning instructions.The scope is being brushed during manual cleaning.The scope is being leak tested.The effective concentration is being checked between each scope reprocessing.There are no issues with the aer.Flushing (air) into the channel of the scope is done after reprocessing.There have been no changes to the reprocessing personnel.The scope has been removed from service.A review of the service history indicated the scope was purchased on june 13, 2012 with six repairs in the past three years; no repairs involving cross contamination issues and four repairs related to leaks in the scope.As part of the investigation, an olympus endoscopy support specialist (ess) was requested to be dispatched to the user facility to observe the facility¿s reprocessing practice and to provide a reprocessing training.To date, the ess visit has not been finalized.The exact cause of the reported event cannot be determined.However, if additional information becomes available, this report will be updated accordingly.This reported event has been reported by the importer on mdr# 2951238-2019-01197.
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