The device referenced in this report is not available for evaluation.As part of the investigation, an olympus endoscopy support specialist (ess) was dispatched to the facility to observe reprocessing practices and to provide training or in-service.The ess found the facility uses a non-olympus automated endoscope reprocessor and understood that the guidelines for their unit would have to be provided by the manufacturer.The ess completed an in-service and provided training to the facility's staff on the appropriate cleaning and reprocessing method.The exact cause of the reported event could not be conclusively determined at this time.Please cross reference mfr.Report numbers: 2951238-2016-00080, 2951238-2016-00081, 2951238-2016-00082, and 2951238-2016-00083 to account for the five patients involved in this event.
|