AMSCO EVOLUTION
Received Oct 10, 2025 · Event occurred Sep 10, 2025
Report 3005899764-2025-00083 · MDR key 23270905
Device
Generic name
Amsco Evolution Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
HC-1500Catalog number
UE06
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
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 THE UPPER PANEL OF THEIR AMSCO EVOLUTION STERILIZER FELL AND CONTACTED AN EMPLOYEE'S HEAD. THE EMPLOYEE DID NOT SEEK MEDICAL TREATMENT AND CONTINUED TO WORK. 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 SCREWS THAT HOLD THE UPPER PANEL WERE LOOSE, SUBSEQUENTLY CAUSING THE REPORTED EVENT. A CAUSE OF THE LOOSE SCREWS COULD NOT BE DETERMINED. TO RESOLVE THE ISSUE, THE TECHNICIAN REATTACHED THE UPPER PANEL AND THE SCREWS THAT HOLD IT. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.