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Description of Event or Problem

THE USER FACILITY REPORTED THAT WHILE AN EMPLOYEE WAS LOADING THEIR STERILIZER, THE EVOLUTION TRANSFER CARRIAGE BECAME UNSTABLE AND FELL TO THE FLOOR. NO REPORT OF INJURY.

Additional Manufacturer Narrative

THE USER FACILITY STATED THAT THEY FOUND THAT THE LATCHING SYSTEM OF THE TRANSFER CARRIAGE WAS MISALIGNED AND WOULD NOT REMAIN ENGAGED WITH THE STERILIZER SUBSEQUENTLY CAUSING THE REPORTED EVENT. THE USER FACILITY'S BIOMED DEPARTMENT DECLINED AN INSPECTION FROM A STERIS SERVICE TECHNICIAN AND ELECTED TO INSPECT AND REPAIR THE LATCHING COMPONENTS OF THE TRANSFER CARRIAGE THEMSELVES. THIS UNIT IS NOT UNDER STERIS SERVICE AGREEMENT FOR MAINTENANCE ACTIVITIES. THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. A STERIS ACCOUNT MANAGER PROVIDED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE EVOLUTION TRANSFER CARRIAGE, INCLUDING PROPER MAINTENANCE ACTIVITIES AND PROPERLY ENGAGING THE TRANSFER CARRIAGE TO THE STERILIZER. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. UDI RELATED DATA CLARIFICATION - THE LOT/SERIAL NUMBER IS UNKNOWN; THEREFORE, THE APPLICABLE PRODUCTION IDENTIFIERS WERE NOT INCLUDED IN THE MDR.