AMSCO
Received Oct 23, 2025 · Event occurred Sep 25, 2025
Report 3005899764-2025-00085 · MDR key 23369221
Device
Generic name
Amsco 400 Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 400 STEAM STERILIZERCatalog number
SR2322211011
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
NA · Unknown
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE EVENT TO INSPECT THE AMSCO 400 STERILIZER AND FOUND THE GUIDE RAILS WITHIN THE STERILIZER TO BE MISALIGNED. AS THE GUIDE RAILS WERE MISALIGNED, THIS CAUSED THE LOADING RACKS TO NOT ENGAGE PROPERLY SUBSEQUENTLY CAUSING THE REPORTED EVENT TO OCCUR. THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE PROPER LOADING AND UNLOADING PROCEDURES. THE TECHNICIAN ADJUSTED THE STERILIZER RAILS TO ENSURE THE LOADING RACKS ENGAGED PROPERLY, TESTED THE FUNCTION AND OPERATION OF THE STERILIZER, CONFIRMED IT TO BE OPERATING TO SPECIFICATION AND RETURNED THE STERILIZER TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE "PULLED A MUSCLE" WHILE UNLOADING A CART FROM THEIR AMSCO 400 STERILIZER. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.