AMSCO
Received Jul 25, 2025 · Event occurred Jun 27, 2025
Report 3005899764-2025-00064 · MDR key 22612532
Device
Generic name
Amsco 400 Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 400 STEM STERILIZERCatalog number
SR2222213011
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE USER FACILITY REPORTED THAT THE DOORS TO TWO OF THEIR AMSCO 400 STERILIZERS ARE "HANGING OFF". NO REPORT OF INJURY.
Description of Event or Problem
THE USER FACILITY REPORTED THAT THE DOOR OF THEIR AMSCO 400 STERILIZER WAS "HANGING OFF". NO REPORT OF INJURY.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND THAT THE DOOR HAD BEEN REINSTALLED BY USER FACILITY PERSONNEL. THE USER FACILITY ELECTED TO MAKE THE REPAIRS THEMSELVES. WHILE ONSITE, THE TECHNICIAN TESTED THE FUNCTION AND OPERATION OF THE UNIT, AND NO ISSUES WERE NOTED. THE STERILIZER WAS RETURNED TO SERVICE. AN EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS THE REPAIRS TO THE UNIT WERE COMPLETED PRIOR TO THE TECHNICIAN'S INSPECTION. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.