The service center was informed that a patient contracted a pseudomonas infection after undergoing an unspecified procedure with the cystoscope.The user facility reported that there was blood in the patient¿s urine.The patient¿s course of treatment is unknown.As part of our investigation , the service center followed up with the customer to obtain additional information regarding the reported event and was informed that the source of the infection has not been determined as an investigation is ongoing.In addition, an endoscopy support specialist (ess) was dispatched on (b)(4) 2020, to observe the user facility¿s reprocessing methods and provide an in-service.The ess reported that there were no reprocessing deviations noted with the facility¿s reprocessing practices.However, an in-service was provided that included reprocessing training, brushing, flushing and sterilization.The scope was returned to the service center and is pending physical evaluation and microbial testing.The scope will be sent to an independent laboratory for microbial testing.This is 2 of 2 reports.
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