AMSCO
Received Jan 15, 2026 · Event occurred Nov 24, 2025
Report 3005899764-2026-00005 · MDR key 24089486
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 400 STEAM STERILIZERCatalog number
SR3201110111
Product problems
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE AMSCO 400 STERILIZER AND FOUND THE VIEW PORT ON THE STERILIZER'S STEAM GENERATOR WAS DAMAGED. AS THE VIEW PORT WAS DAMAGED, THIS ALLOWED WATER AND STEAM TO LEAK OUT ONTO THE FLOOR. THE TECHNICIAN REPLACED THE VIEW PORT, TESTED THE FUNCTION AND OPERATION OF THE DEVICE AND CONFIRMED IT TO BE OPERATING TO SPECIFICATIONS. THE UNIT WAS RETURNED TO SERVICE, AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT STEAM AND WATER LEAKED FROM THEIR AMSCO 400 STERILIZER. NO REPORT OF INJURY.