V-PRO

Description of Event or Problem

THE USER FACILITY REPORTED VIA A CHEMTREC REPORT THAT AN EMPLOYEE EXPERIENCED A "BURN" TO THEIR HAND FROM UNWRAPPING AN INSTRUMENT THAT WAS PROCESSED IN THEIR STERILIZER. THE EMPLOYEE RINSED THEIR HANDS WITH WATER. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS ADMINISTERED.

Additional Manufacturer Narrative

STERIS MADE MULTIPLE ATTEMPTS TO CONTACT THE USER FACILITY EMPLOYEE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

THE BRAND NAME LISTED IN OUR INITIAL MDR # 3005899764-2024-00046 WAS FOR THE V-PRO MAX STERILIZER. OUR FOLLOW-UP INVESTIGATION IN MDR 3005899764-2024-00046-01 DETERMINED THAT THE REPORTED EVENT OCCURRED WITH A V-PRO MAX 2 STERILIZER, THEREFORE, THE BRAND NAME WAS UPDATED ACCORDINGLY.

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 REPAIRS WERE MADE AND THE UNIT WAS RETURNED TO SERVICE. IT WAS CONFIRMED THAT THE EMPLOYEE SUBJECT OF THE REPORTED EVENT WAS NOT WEARING PROPER PPE, SPECIFICALLY GLOVES WHILE HANDLING THE PROCESSED INSTRUMENT PACK. THE EMPLOYEE DID NOT SEEK MEDICAL TREATMENT AND RETURNED TO WORK THE NEXT DAY. THE V-PRO MAX 2 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 2 OPERATOR MANUAL FURTHER 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 AND/OR A CYCLE ABORT OCCURS. C. ONLY DRY ITEMS ARE TO BE PLACED IN STERILIZATION UNIT." THE USER FACILITY WAS PROVIDED VERBAL COUNSELING ON THE IMPORTANCE OF WEARING PROPER PPE, SPECIFICALLY GLOVES, WHILE OPERATING THEIR V-PRO MAX 2 STERILIZER. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.