AMSCO
Received Sep 12, 2025 · Event occurred Aug 13, 2025
Report 3005899764-2025-00076 · MDR key 23037654
Device
Generic name
Amsco 400 Steam Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 400 STEAM STERILIZERCatalog number
SR0201110311
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 FOLLOWING THE REPORTED EVENT. UPON THE TECHNICIAN'S ARRIVAL, USER FACILITY PERSONNEL DECLINED TO HAVE THE AMSCO 400 STERILIZER INSPECTED BY STERIS AND STATED THEY WILL BE REMOVING THE UNIT FROM SERVICE. THE TECHNICIAN WAS ABLE TO OBSERVE DAMAGE TO THE FACILITY'S HOT WATER LINE HOWEVER, WITHOUT THE INSPECTION AND EVALUATION OF THE AMSCO 400 STERILIZER A CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE STERILIZER SUBJECT OF THE REPORTED EVENT IS NOT UNDER STERIS SERVICE AGREEMENT FOR MAINTENANCE ACTIVITIES; THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.
Description of Event or Problem
THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR AMSCO 400 STERILIZER. NO REPORT OF INJURY.