inforMED
MalfunctionFLE

AMSCO EVOLUTION

Received May 27, 2026 · Event occurred Apr 29, 2026

Report 3005899764-2026-00039 · MDR key 25302569

Device

Generic name

Sterilizer

Model number

HC-2000

Catalog number

UE41

Product problems

  • Use of Device Problem

Patient

NA · Unknown

  • Limb Pain

Narrative

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND THAT A STERILIZER CART HAD BECOME JAMMED IN THE DOOR. WHEN USER FACILITY PERSONNEL ATTEMPTED TO PUSH THE STERILIZER CART INTO THE UNIT, THE DOOR CONTACTED THE EMPLOYEE'S HAND. THE CAUSE OF THE REPORTED EVENT WAS THE IMPROPER LOADING OF THE MEDIUM EVOLUTION STERILIZER CART. THE TECHNICIAN TESTED THE FUNCTION AND OPERATION OF THE UNIT, CONFIRMED IT TO BE OPERATING TO SPECIFICATION, AND RETURNED IT TO SERVICE. NO REPAIRS WERE REQUIRED. THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE MEDIUM EVOLUTION STERILIZER, SPECIFICALLY ON THE PROPER LOADING OF THE STERILIZER. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT WHILE HANDLING THE CART INSIDE OF THEIR MEDIUM EVOLUTION STERILIZER, THE DOOR CLOSED AND CONTACTED THE EMPLOYEE'S HAND. MEDICAL TREATMENT WAS SOUGHT; HOWEVER, IT IS UNKNOWN WHAT MEDICAL TREATMENT WAS ADMINISTERED.