ATLAS

Additional Manufacturer Narrative

THE INVESTIGATION FOR THE REPORTED EVENT IS IN PROGRESS; A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THE DEVICE SUBJECT OF THE EVENT WAS MANUFACTURED PRIOR TO UDI COMPLIANCE, THEREFORE, UDI IS NOT APPLICABLE AND WAS NOT INCLUDED IN THE MDR.

Description of Event or Problem

THE USER FACILITY REPORTED THAT AFTER AN EMPLOYEE UNLOADED THEIR TRANSFER CART FROM THEIR STERILIZER AFTER A CYCLE, THE CART ROLLED OUT AND THE EMPLOYEE OBTAINED A BURN ON THEIR FOREARM AFTER CONTACTING THE CART. THE EMPLOYEE SOUGHT MEDICAL TREATMENT AT THE EMERGENCY ROOM.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ON SITE TO INSPECT THE ATLAS TRANSFER CARRIAGE. THE TECHNICIAN IDENTIFIED THAT THE REAR CASTER WHEEL WAS DAMAGED, THE WHEEL WAS NOT SCREWED IN ALL THE WAY, AND THE WHEEL BRACKET HAD DETACHED. DUE TO ITS AGE AND CONDITION, THE USER FACILITY ELECTED NOT TO REPAIR THE CARRIAGE AND PERMANENTLY REMOVED IT FROM SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.