MalfunctionFLE
AMSCO
Received Apr 9, 2026 · Event occurred Mar 11, 2026
Report 3005899764-2026-00028 · MDR key 24831363
Device
Generic name
Steam Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 400 STEAM STERILIZERCatalog number
SR0201110311
Product problems
- Pressure Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT AND FOUND THE VIEWPORT TO BE DAMAGED. THE TECHNICIAN REPLACED THE VIEWPORT, TESTED THE FUNCTION AND OPERATION OF THE AMSCO 400 STERILIZER, CONFIRMED IT TO BE OPERATING TO SPECIFICATIONS AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT DURING A CYCLE, THEIR AMSCO 400 STERILIZER MADE A "LOUD NOISE" AND STATED STEAM AND WATER WERE LEAKING FROM THE UNIT. NO REPORT OF INJURY.