AMSCO
Received Aug 7, 2025 · Event occurred Jul 9, 2025
Report 3005899764-2025-00067 · MDR key 22743415
Device
Generic name
Amsco 400 Steam Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 400 STEAM STERILIZERCatalog number
SR2221211011
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- Bruise/Contusion
- Bruise/Contusion
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND THAT THE LATCHING SYSTEM OF THE UNIT WAS MISALIGNED. THE TECHNICIAN ADJUSTED THE PANEL SUPPORT BRACKET, TESTED THE UNIT AND 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 BOTTOM PANEL TO THEIR AMSCO 400 STERILIZER DETACHED AND CONTACTED THE EMPLOYEE'S FOOT (BRUISE). THE EMPLOYEE WENT TO THE EMERGENCY ROOM. THE USER FACILITY DID NOT DISCLOSE FURTHER MEDICAL INFORMATION.