AMSCO
Received Oct 10, 2025 · Event occurred Sep 11, 2025
Report 3005899764-2025-00084 · MDR key 23268650
Device
Generic name
Amsco 600 Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 600 STEAM STERILIZERCatalog number
EF1101122
Product problems
- Leak/Splash
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE AMSCO 600 STERILIZER AND FOUND THAT THE HEATING ELEMENT OF THE UNIT WAS DAMAGED RESULTING IN THE REPORTED EVENT. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE TECHNICIAN REPLACED THE HEATING ELEMENT AND PROACTIVELY REPLACED THE CHECK VALVE, SAFETY VALVE, GENERATOR CONTACTOR AND WATER PUMP. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. A 3-YEAR COMPLAINT REVIEW CONFIRMED THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT THEIR AMSCO 600 STERILIZER LEAKED STEAM AND WATER ONTO THE FLOOR. NO REPORT OF INJURY.