AMSCO
Received Feb 12, 2026 · Event occurred Jan 13, 2026
Report 3005899764-2026-00011 · MDR key 24326067
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 400 STEAM STERILIZERCatalog number
SR0201110111
Product problems
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT THEIR AMSCO 400 STEAM STERILIZER WAS LEAKING WATER ONTO THE FLOOR. NO REPORT OF INJURY.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE STERILIZER AND FOUND THAT THE STERILIZER'S GENERATOR PIPING REQUIRED ADJUSTMENT. WHILE ONSITE THE TECHNICIAN ADJUSTED THE GENERATOR PIPING, PROACTIVELY REPLACED THE FLOW REGULATOR AND CHECK VALVE, TESTED THE UNIT, AND CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION. THE STERILIZER WAS RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.