Steris opened a service request on 1/30/2023 to have preventive maintenance activities performed on the advantage plus automated endoscope reprocessor.The preventive maintenance kit containing all service components was ordered in february 2023 and received in march 2023.Following the receipt of the preventive maintenance kit, a steris service technician completed all preventive maintenance activities on 3/29/2023 and returned the unit to service.Steris evaluated the reported event and determined it does not meet our reporting criteria under 21 cfr part 803.It should be noted that steris is submitting a medical device report (mdr) solely due to the receipt of the user facility medwatch report which is in accordance with our procedures and policies.No additional issues have been reported.
|