V-PRO MAX STERILIZER

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE V-PRO MAX STERILIZER AND FOUND THE UNIT TO BE OPERATING PROPERLY. NO ISSUES WITH THE FUNCTION OR OPERATION OF THE STERILIZER WERE IDENTIFIED. THE UNIT WAS RETURNED TO SERVICE. IT WAS REPORTED THAT THE EMPLOYEE SUBJECT OF THE REPORTED EVENT WAS NOT WEARING PROPER PPE, SPECIFICALLY GLOVES, AT THE TIME OF THE REPORTED EVENT. THE TECHNICIAN COULD NOT DETERMINE WHAT CAUSED THE TRAY TO BE WET. THE V-PRO MAX STERILIZER OPERATOR MANUAL STATES (PP. 6-14), "ANSI/AAMI ST58, 2013, RECOMMENDS USING CHEMICAL-RESISTANT GLOVES WHEN USING THE STERILIZATION UNIT. THE V-PRO MAX STERILIZER OPERATOR MANUAL FURTHER (1-2) STATES, "DANGER - CHEMICAL INJURY HAZARD: ANY VISIBLE LIQUIDS IN THE CHAMBER OR ON THE LOAD MUST BE TREATED AS CONCENTRATED HYDROGEN PEROXIDE. OBSERVE ALL HYDROGEN PEROXIDE HANDLING PRECAUTIONS. WHEN HANDLING HYDROGEN PEROXIDE, WEAR APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT." STERIS COUNSELED USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE V-PRO MAX STERILIZER, SPECIFICALLY THE IMPORTANCE OF WEARING PROPER PPE WHILE HANDLING INSTRUMENTS THAT HAVE BEEN PROCESSED IN 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 THAT AN EMPLOYEE EXPERIENCED A BURN TO THEIR FINGERS AFTER OPENING A TRAY THAT WAS PREVIOUSLY PROCESSED IN THEIR V-PRO MAX STERILIZER. THE EMPLOYEE VISITED THE ER; HOWEVER, IT WAS NOT DISCLOSED IF MEDICAL TREATMENT WAS ADMINISTERED.