V-PRO 60

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT BOTH STERILIZERS; BOTH UNITS WERE FOUND TO BE OPERATING PROPERLY. FOR ONE OF THE UNITS, TWO REPAIRS UNRELATED TO THE REPORTED EVENT WERE MADE. NO ISSUES WITH THE FUNCTION OR THE OPERATION OF THE STERILIZERS WERE IDENTIFIED, AND THE UNITS WERE RETURNED TO SERVICE. THE TECHNICIAN LEARNED THE EMPLOYEES WERE 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 COUNSELED THE 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 TO WEAR PROPER PPE WHILE HANDLING INSTRUMENTS TO THE STERILIZER. 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.

Description of Event or Problem

THE USER FACILITY REPORTED TWO EMPLOYEES OBTAINED A BURN TO THEIR FINGERS WHILE HANDLING ITEMS PROCESSED ONE OF THEIR TWO V-PRO 60 STERILIZERS. BOTH EMPLOYEES RINSED THEIR HANDS WITH WATER FOLLOWING THE REPORTED EVENT. MEDICAL TREATMENT WAS SOUGHT, IT WAS NOT DISCLOSED IF ANY TREATMENT WAS ADMINISTERED TO THE FIRST EMPLOYEE. IT WAS CONFIRMED THAT NO MEDICAL TREATMENT WAS ADMINISTERED TO THE SECOND EMPLOYEE. BOTH EMPLOYEES RETURNED TO WORK.