EVOLUTION TRANSFER CARRIAGE

Additional Manufacturer Narrative

IN LIEU OF REPAIRING THE EVOLUTION TRANSFER CARRIAGE, THE USER FACILITY HAS ELECTED TO DISCONTINUE USE OF THE EVOLUTION STERILIZER AND EVOLUTION TRANSFER CARRIAGE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE EVOLUTION TRANSFER CARRIAGE AND FOUND THE LOCKING MECHANISM TO BE DAMAGED. BECAUSE OF THE DAMAGE, THE LOCKING MECHANISM WAS ABLE TO BECOME DISENGAGED WHEN FORCE WAS APPLIED TO THE CARRIAGE RESULTING IN THE REPORTED EVENT. THIS UNIT IS NOT UNDER STERIS SERVICE AGREEMENT FOR MAINTENANCE ACTIVITIES. THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. BASED ON THE TECHNICIAN'S INSPECTION AND THE DAMAGE TO THE LOCKING MECHANISM, THE REPORTED EVENT IS LIKELY ATTRIBUTED TO USER ERROR AS THE TRANSFER CARRIAGE MAY HAVE HAD SUSTAINED IMPACT DAMAGE AND SUBSEQUENTLY NOT REPAIRED. THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE EVOLUTION TRANSFER CARRIAGE. THE CARRIAGE HAS BEEN REMOVED FROM SERVICE AND IS PENDING REPAIRS. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED THAT WHILE AN EMPLOYEE WAS OPERATING THEIR EVOLUTION TRANSFER CARRIAGE, IT BECAME UNSTABLE AND FELL TO THE FLOOR RESULTING IN AN INJURY.