V-PRO MAX STERILIZER

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT AND FOUND THAT THE UNIT HAD BEEN REMOVED FROM SERVICE BY USER FACILITY PERSONNEL. THE TECHNICIAN INSPECTED THE UNIT AND FOUND IT TO BE OPERATING PROPERLY. NO ISSUES WERE NOTED WITH THE FUNCTION OR OPERATION. ALTHOUGH THE UNIT WAS OPERATING TO SPECIFICATIONS, THE TECHNICIAN PROACTIVELY REPLACED THE INJECTION CYLINDER AND TWO CHECK VALVES. THE TECHNICIAN TESTED THE FUNCTION AND OPERATION, CONFIRMED THE UNIT TO BE OPERATING TO SPECIFICATION AND RETURNED THE UNIT SERVICE. THE TECHNICIAN WAS INFORMED THAT THE EMPLOYEE WAS NOT WEARING PROPER PPE, SPECIFICALLY GLOVES, WHILE OPERATING 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." THE V-PRO MAX OPERATOR MANUAL (1-2) STATES, "ANSI/AAMI ST58, 2013, RECOMMENDS USING CHEMICAL-RESISTANT GLOVES WHEN USING THE STERILIZATION UNIT." ADDITIONALLY, USER FACILITY PERSONNEL SHOULD ENSURE ALL INSTRUMENTS ARE PROPERLY DRY PRIOR TO PLACEMENT IN THE V-PRO MAX STERILIZER. THE V-PRO MAX OPERATOR MANUAL, (A-1) STATES, "DRY ALL ITEMS THOROUGHLY. ENSURE ALL MOISTURE IS REMOVED FROM ALL INTERNAL PARTS (INCLUDING LUMENS). IF NOT, RESIDUAL HYDROGEN PEROXIDE MAY REMAIN AT CYCLE COMPLETION AND/OR A CYCLE ABORT OCCURS. ONLY DRY ITEMS ARE TO BE PLACED IN STERILIZATION UNIT." THE STERIS SERVICE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION FOR THE V-PRO MAX STERILIZER AND THE IMPORTANCE OF WEARING PROPER PPE AND DRYING INSTRUMENTS BEFORE PROCESSING. STERIS EVALUATED THE REPORTED EVENT AND DETERMINED IT DOES NOT MEET OUR REPORTING CRITERIA UNDER 21 CFR PART 803. IT SHOULD BE NOTED THAT STERIS IS SUBMITTING A MEDICAL DEVICE REPORT (MDR) SOLELY DUE TO THE RECEIPT OF THE USER FACILITY MEDWATCH REPORT WHICH IS IN ACCORDANCE WITH OUR PROCEDURES AND POLICIES. 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 VIA MEDWATCH #(B)(4) THAT TWO EMPLOYEES FELT A BURNING SENSATION ON THEIR FINGERS UPON OPENING AN INSTRUMENT PACK THAT WAS PROCESSED IN THEIR V-PRO MAX STERILIZER. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.