EVOLUTION TRANSFER CARRIAGE
Received Jul 11, 2025 · Event occurred Jun 12, 2025
Report 3005899764-2025-00057 · MDR key 22482355
Device
Generic name
Carriage
Manufacturer
Steris Mexico, S. De R.l. De C.v.Product problems
- Mechanical Problem
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT WHILE AN EMPLOYEE WAS LOADING THEIR STERILIZER, THE EVOLUTION TRANSFER CARRIAGE BECAME UNSTABLE AND FELL TO THE FLOOR. NO REPORT OF INJURY.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND THAT THE LATCHING SYSTEM OF THE CARRIAGE WAS MISALIGNED, SUBSEQUENTLY CAUSING THE REPORTED EVENT. TO RESOLVE THE ISSUE, THE TECHNICIAN READJUSTED THE LATCHING SYSTEM. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. 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.