V-PRO

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE V-PRO S2 STERILIZER AND FOUND THE UNIT TO BE OPERATING PROPERLY. NO ISSUES WERE NOTED WITH THE FUNCTION OR OPERATION OF THE UNIT AND THE STERILIZER WAS RETURNED TO SERVICE. THE TECHNICIAN WAS INFORMED THAT THE EMPLOYEE WAS NOT WEARING PROPER PPE, SPECIFICALLY GLOVES, WHILE OPERATING THE STERILIZER. THE V-PRO S2 STERILIZER OPERATOR MANUAL 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 OPERATOR MANUAL FURTHER 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 S2 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." THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE IMPORTANCE OF WEARING PROPER PPE, SPECIFICALLY GLOVES, WHILE OPERATING THEIR V-PRO S2 STERILIZER AND PROPERLY DRYING INSTRUMENTS PRIOR TO PROCESSING. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

USER FACILITY PERSONNEL STATED THE EMPLOYEE SUBJECT OF THE REPORTED EVENT SOUGHT MEDICAL TREATMENT AT THE ER. THE USER FACILITY DID NOT DISCLOSE THE TYPE OF TREATMENT THAT MAY HAVE BEEN ADMINISTERED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN TO THEIR FINGERTIP AFTER HANDLING AN INSTRUMENT POUCH THAT WAS PROCESSED IN THEIR V-PRO S2 STERILIZER. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

Additional Manufacturer Narrative

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