AMSCO LOADING CART

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ON-SITE FOLLOWING THE REPORTED EVENT TO INSPECT THE STERILIZER. THE TECHNICIAN FOUND NO ISSUES WITH THE UNIT AND FOUND IT TO BE OPERABLE ACCORDING TO SPECIFICATIONS. UPON FURTHER INSPECTION THE TECHNICIAN FOUND THAT THE LOADING CART RAILS HAD A SHARP CORNER, APPARENTLY DUE TO IMPACT DAMAGE, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. TO RESOLVE THE ISSUE, THE TECHNICIAN REPAIRED THE CORNER ON THE LOADING CART AND RETURNED THE UNIT TO SERVICE. A 3-YEAR COMPLAINT REVIEW DETERMINED THIS TO BE AN ISOLATED EVENT. AT THIS TIME, THE USER FACILITY WAS UNABLE TO IDENTIFY THE SERIAL NUMBER OF THE LOADING CART OF THE REPORTED EVENT. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. UDI RELATED DATA CLARIFICATION - THE LOT/SERIAL NUMBER IS UNKNOWN, THEREFORE, THE APPLICABLE PRODUCTION IDENTIFIERS WERE NOT INCLUDED IN THE MDR."

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A CUT ON THEIR FINGER WHILE LOADING A CART INTO THEIR 60" PRE VACUUM STERILIZER. THE EMPLOYEE'S FINGER REQUIRED STITCHES.