V-PRO 60 STERILIZER

Description of Event or Problem

THE USER FACILITY REPORTED AN EMPLOYEE OBTAINED A BURN TO THEIR FINGER WHILE HANDLING ITEMS PROCESSED IN THEIR V-PRO 60 STERILIZER. MEDICAL TREATMENT WAS SOUGHT, AND OINTMENT WAS ADMINISTERED. THE EMPLOYEE RETURNED TO WORK.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE STERILIZER AND FOUND IT TO BE OPERATING PROPERLY. NO ISSUES WITH THE FUNCTION OR OPERATION OF THE STERILIZER WERE IDENTIFIED, AND THE STERILIZER WAS RETURNED TO SERVICE. THE TECHNICIAN LEARNED THE EMPLOYEE WAS NOT WEARING PROPER PPE, SPECIFICALLY GLOVES, AT THE TIME OF THE REPORTED EVENT. THE V-PRO 60 STERILIZER OPERATOR MANUAL STATES (6-19), "ANSI/AAMI ST58, 2013, RECOMMENDS USING CHEMICAL-RESISTANT GLOVES WHEN USING THE STERILIZATION UNIT." THE OPERATION MANUAL FURTHER STATES, "PERSONAL PROTECTIVE EQUIPMENT- STERIS RECOMMENDS WEARING CHEMICAL RESISTANT GLOVES WHEN HANDLING STERILANT CUP OR UNLOADING STERILIZATION UNIT." ADDITIONALLY, USER FACILITY PERSONNEL SHOULD ENSURE THAT INSTRUMENTS ARE PROPERLY DRIED PRIOR TO PLACEMENT INTO THE V-PRO 60 STERILIZER. THE V-PRO 60 STERILIZER OPERATOR MANUAL STATES (A-1), "CLEANING, RINSING, AND DRYING- ALL ITEMS MUST FIRST BE THOROUGHLY CLEANED, RINSED, AND DRIED BEFORE BEING PACKAGED AND LOADED INTO THE V-PRO 60 STERILIZER." A STERIS ACCOUNT MANAGER WILL PERFORM IN-SERVICE TRAINING TO THE USER FACILITY ON THE PROPER USE AND OPERATION OF THE V-PRO 60 STERILIZER; THIS IS SCHEDULED FOR (B)(6) 2025). NO ADDITIONAL ISSUES HAVE BEEN REPORTED. UDI RELATED DATA CLARIFICATION - THE DEVICE SUBJECT OF THE EVENT WAS MANUFACTURED PRIOR TO UDI COMPLIANCE; THEREFORE, UDI IS NOT APPLICABLE AND WAS NOT INCLUDED IN THE MDR.

Additional Manufacturer Narrative

A STERIS ACCOUNT MANAGER CONDUCTED IN-SERVICE TRAINING WITH USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE V-PRO 60 STERILIZER; SPECIFICALLY, TO ENSURE ALL INSTRUMENTS ARE PROPERLY DRIED BEFORE PROCESSING AND THE IMPORTANCE OF WEARING PROPER PPE WHILE HANDLING INSTRUMENTS THAT HAVE BEEN PROCESSED IN THE STERILIZER. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.