AMSCO V-PRO

Additional Manufacturer Narrative

THE USER FACILITY DECLINED TO HAVE STERIS INSPECT THE STERILIZER SUBJECT OF THE REPORTED EVENT AND ELECTED TO PERFORM THEIR OWN INTERNAL EVALUATION. USER FACILITY PERSONNEL STATED TO STERIS THAT NO ISSUES WERE NOTED WITH THE FUNCTION OR OPERATION OF THE STERILIZER DURING THEIR EVALUATION. THROUGH FOLLOW-UP WITH USER FACILITY PERSONNEL, IT WAS DISCOVERED THAT THE EMPLOYEE SUBJECT OF THE REPORTED EVENT WAS NOT WEARING THE PROPER PPE, SPECIFICALLY GLOVES, WHILE HANDING PACKS PROCESSED IN THE V-PRO MAX STERILIZER. THE V-PRO MAX STERILIZER OPERATOR MANUAL (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." ADDITIONALLY, THE V-PRO MAX STERILIZER OPERATOR MANUAL STATES (A-1), "A. DRY ALL ITEMS THOROUGHLY. B. ENSURE ALL MOISTURE IS REMOVED FROM ALL INTERNAL PARTS (INCLUDING LUMENS). IF NOT, RESIDUAL HYDROGEN PEROXIDE MAY REMAIN AT CYCLE COMPLETION." STERIS HAS OFFERED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE V-PRO MAX STERILIZER AND IS AWAITING A RESPONSE. 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.

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN TO THEIR HANDS AFTER HANDLING A TRAY THAT WAS PROCESSED IN THEIR V-PRO MAX STERILIZER. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.