MalfunctionFLE
AMSCO
Received May 15, 2026 · Event occurred Apr 17, 2026
Report 3005899764-2026-00037 · MDR key 25188546
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 400 STEAM STERILIZERCatalog number
SR0201110311
Product problems
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED WATER AND STEAM LEAKING FROM THEIR AMSCO 400 STERILIZER ONTO THE FLOOR. NO REPORT OF INJURY.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT AND FOUND THE VIEWPORT WAS DAMAGED ALLOWING WATER TO LEAK FROM THE STERILIZER. THE TECHNICIAN REPLACED THE VIEWPORT, TESTED THE UNIT, CONFIRMED THE UNIT TO BE OPERATING ACCORDING TO SPECIFICATION, AND THE UNIT WAS RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.