V-PRO MAX STERILIZER

Additional Manufacturer Narrative

THE USER FACILITY REPORTED THAT THEY COULD NOT DETERMINE OUT OF THE THREE V-PRO MAX STERILIZERS AT THE FACILITY WHICH ONE PROCESSED THE INSTRUMENT FROM THE REPORTED EVENT (SERIAL NUMBERS: (B)(6). A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT ALL THREE UNITS. ALL THREE WERE CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION. NO REPAIRS WERE MADE, AND THE UNITS WERE RETURNED TO SERVICE. THE TECHNICIAN WAS INFORMED THAT IT WAS UNKNOWN IF THE EMPLOYEE SUBJECT OF THE REPORTED EVENT WAS WEARING PROPER PPE, SPECIFICALLY GLOVES, WHILE OPERATING THE V-PRO MAX STERILIZER. THE V-PRO MAX STERILIZER OPERATOR MANUAL (6.3) 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. REFER TO THE STERILANT SAFETY DATA SHEET (SDS) FOR APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE; REFER TO GLOSSARY), SPILL CONTAINMENT AND CLEANUP." THE V-PRO MAX OPERATOR MANUAL (6.6) 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, (10.1) 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." USER FACILITY PERSONNEL WERE COUNSELED ON THE PROPER USE AND OPERATION OF THE V-PRO MAX STERILIZER, SPECIFICALLY THE IMPORTANCE OF WEARING PROPER PPE AND THOROUGHLY DRYING INSTRUMENTS PRIOR TO PROCESSING. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

THE INVESTIGATION IS CURRENTLY IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN ON THEIR HAND WHILE RETRIEVING THEIR AIR PROBE SENSOR AFTER BEING STERILIZED FROM A V-PRO MAX STERILIZER.