AMSCO EVOLUTION

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND THAT A SCREW AT THE TOP PANEL OF THE STERILIZER WAS MISSING, SUBSEQUENTLY CAUSING THE REPORTED EVENT. THE LAST PREVENTIVE MAINTENANCE OF THE MEDIUM EVOLUTION STERILIZER WAS CONDUCTED IN OCTOBER 2024. IT IS UNKNOWN IF USER FACILITY PERSONNEL REMOVED THE PANEL DURING THAT TIME. TO RESOLVE THE ISSUE, THE TECHNICIAN REINSTALLED THE TOP PANEL AND THE SCREW. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED AN EMPLOYEE OBTAINED A CONCUSSION AFTER THE TOP PANEL OF THEIR MEDIUM EVOLUTION STERILIZER FELL AND CONTACTED THE EMPLOYEE'S HEAD. THE EMPLOYEE VISITED THE EMERGENCY ROOM; HOWEVER, IT IS UNKNOWN IF ANY MEDICAL TREATMENT WAS ADMINISTERED.