inforMED
MalfunctionFLE

AMSCO EVOLUTION

Received Jul 29, 2025 · Event occurred Jun 29, 2025

Report 3005899764-2025-00065 · MDR key 22643188

Device

Generic name

Amsco Evolution Sterilizer

Model number

HC-1500

Catalog 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.