AMSCO
Received Dec 4, 2025 · Event occurred Nov 7, 2025
Report 3005899764-2025-00096 · MDR key 23717384
Device
Generic name
Amsco 400 Steam Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 400 STEAM STERILIZERCatalog number
SR0201110111
Product problems
- Electrical /Electronic Property Problem
- Insufficient Device Problem Information
- Electrical /Electronic Property Problem
- Insufficient Device Problem Information
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 400 STERILIZER AND FOUND THAT THE GENERATOR MOTOR WAS DAMAGED AND REQUIRED REPLACEMENT. THE TECHNICIAN REPLACED THE GENERATOR MOTOR, TESTED THE FUNCTION AND OPERATION OF THE STERILIZER AND CONFIRMED IT TO THE OPERATING TO SPECIFICATION. THE STERILIZER WAS RETURNED TO SERVICE, AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED. THE GENERATOR MOTOR SUBJECT OF THE REPORTED EVENT WAS RETURNED FOR EVALUATION. DURING EVALUATION, THE REPORTED EVENT COULD NOT BE DUPLICATED, AND NO ISSUES WERE NOTED WITH THE GENERATOR MOTOR.
Additional Manufacturer Narrative
INVESTIGATION OF THE EVENT IS CURRENTLY IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE USER FACILITY REPORTED THAT SMOKE EMITTED FROM THE BACK OF THEIR AMSCO 400 STERILIZER DURING A CYCLE. NO REPORT OF INJURY.