A steris service technician arrived onsite following the reported event to inspect the eagle 3000 sterilizer and found that the unit could not pull a sufficient vacuum.Upon further inspection, the technician found several parts of the sterilizer were damaged including the s7, s3, and s4 valves.The sterilizer was installed in march 2005 making the unit approximately 14 years old at the time of the reported event.The technician made the necessary repairs, ran a test cycle, and found the sterilizer to be operating according to specification.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.(b)(4).
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