AMSCO EVOLUTION
Received Nov 13, 2023 · Event occurred Oct 14, 2023
Report 3005899764-2023-00064 · MDR key 18125399
Device
Generic name
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
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT AND FOUND THAT THE BOLTS THAT ATTACH THE PANEL TO THE STERILIZER WERE NOT SECURE CAUSING THE REPORTED EVENT TO OCCUR. THE TECHNICIAN REPLACED AND SECURED THE BOLTS, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT THE TOP PANEL ON THEIR 60" EVOLUTION STERILIZER FELL OFF THE UNIT CONTACTING AN EMPLOYEE'S HEAD. MEDICAL TREATMENT WAS SOUGHT AND ADMINISTERED. THE USER FACILITY DID NOT DISCLOSE WHAT MEDICAL TREATMENT WAS ADMINISTERED.
Additional Manufacturer Narrative
UDI RELATED DATA QUALITY UPDATES ONLY - ALIGNMENT WITH GUDID.