AMSCO V-PRO

Additional Manufacturer Narrative

STERIS CONTACTED THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE USER FACILITY COULD NOT IDENTIFY THE STERILIZER SUBJECT OF THE REPORTED EVENT AND REPORTED THAT UPON THEIR INSPECTION, ALL FOUR V-PRO MAX STERILIZERS WERE OPERATIONAL AND NO ISSUES WERE NOTED WITH THE FUNCTION OR OPERATION. NO ISSUES WERE NOTED. ADDITIONALLY, STERIS WAS INFORMED THAT THE EMPLOYEES SUBJECT OF THE REPORTED EVENT WERE NOT WEARING PROPER PPE, SPECIFICALLY GLOVES, WHEN HANDLING THE BIS PROCESSED IN THE 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..." THE V-PRO MAX STERILIZER OPERATOR MANUAL FURTHER STATES, "WHEN HANDLING HYDROGEN PEROXIDE, WEAR APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE; REFER TO GLOSSARY) AND OBSERVE ALL SAFETY PRECAUTIONS. SEE STERILANT SDS, PRODUCT LABEL AND PACKAGE INSERT FOR ADDITIONAL HANDLING INFORMATION." WHILE ON THE PHONE, THE STERIS SERVICE TECHNICIAN COUNSELED THE USER FACILITY ON WEARING THE PROPER PPE WHILE HANDLING ITEMS PROCESSED IN THEIR V-PRO MAX STERILIZER. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT MULTIPLE EMPLOYEES OBTAINED "BURNS" AFTER OPENING INDICATORS THAT WERE PROCESSED FROM THEIR V-PRO MAX STERILIZER. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

Additional Manufacturer Narrative

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