inforMED
MalfunctionFLE

AMSCO EVOLUTION

Received Feb 25, 2026 · Event occurred Jan 25, 2026

Report 3005899764-2026-00015 · MDR key 24446872

Device

Generic name

Amsco Evolution Sterilizer

Model number

HC-1500

Catalog number

UE06

Product problems

  • Detachment of Device or Device Component

Patient

NA · Unknown

  • Insufficient Information

Narrative

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE STERILIZER AND FOUND THAT THE BOLTS THAT SECURE THE UPPER PANEL INTO PLACE WERE ALREADY REPLACED BY THE USER FACILITY. THE TECHNICIAN TESTED THE STERILIZER, CONFIRMED IT TO BE OPERATING TO SPECIFICATIONS AND, RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THE UPPER PANEL OF THEIR AMSCO EVOLUTION STERILIZER DETACHED AND CONTACTED THE EMPLOYEE. THE USER FACILITY DID NOT DISCLOSE FURTHER DETAILS REGARDING THE INJURY OR IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.