AMSCO EVOLUTION
Received Jul 29, 2025 · Event occurred Jun 29, 2025
Report 3005899764-2025-00065 · MDR key 22643188
Device
Generic name
Amsco Evolution Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
HC-1500Catalog number
UE06
Product problems
- Leak/Splash
- Leak/Splash
Patient
NA · Unknown
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT. THE TECHNICIAN INSPECTED THE EVOLUTION STERILIZER AND FOUND THE VACUUM PUMP OVERLOAD RELAY HAD TRIPPED AT THE END OF THE DART CYCLE, CAUSING STEAM TO REMAIN INSIDE THE CHAMBER. THE TECHNICIAN MADE REPAIRS AND ADJUSTMENTS TO THE UNIT, TESTED THE FUNCTION AND OPERATION, AND RETURNED THE UNIT TO SERVICE. A 3-YEAR COMPLAINT REVIEW CONFIRMED THE EVENT TO BE ISOLATED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT FOLLOWING A DART TEST CYCLE AN EMPLOYEE OPENED THE DOOR TO THEIR AMSCO EVOLUTION STERILIZER AND OBTAINED A BURN. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.