MAX 2

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE STERILIZER AND FOUND THE UNIT TO BE OPERATING PROPERLY. NO ISSUES WITH THE FUNCTION OR OPERATION OF THE STERILIZER WERE IDENTIFIED, AND IT WAS RETURNED TO SERVICE. ADDITIONALLY, IT WAS DISCOVERED THAT USER FACILITY PERSONNEL WERE NOT WEARING THE PROPER PPE, SPECIFICALLY GLOVES, WHILE OPERATING THE V-PRO MAX 2 STERILIZER. THE V-PRO MAX 2 STERILIZER OPERATOR MANUAL STATES (1-2), "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, USER FACILITY PERSONNEL SHOULD ENSURE ALL INSTRUMENTS ARE PROPERLY DRY PRIOR TO PLACEMENT IN THE V-PRO MAX 2 STERILIZER. THE OPERATOR MANUAL 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." A STERIS ACCOUNT MANAGER PROVIDED IN-SERVICE TRAINING ON THE IMPORTANCE OF WEARING PROPER PPE, SPECIFICALLY GLOVES, WHILE OPERATING THEIR V-PRO MAX 2 STERILIZER. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN ON THEIR HANDS AFTER HANDLING ITEMS THAT WERE PROCESSED IN A V-PRO MAX 2 STERILIZER. THE EMPLOYEE WASHED THEIR HANDS AND RETURNED TO WORK.