AMSCO
Received Jun 25, 2026 · Event occurred May 28, 2026
Report 3005899764-2026-00045 · MDR key 25627071
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 400 STEAM STERILIZERCatalog number
SR0201210311
Product problems
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT AND FOUND THAT THE VIEWPORT WITHIN THE AMSCO 400 STERILIZER WAS DAMAGED. AS THE VIEWPORT WAS DAMAGED, THIS ALLOWED STEAM TO LEAK OUT DURING A CYCLE. THE TECHNICIAN REPLACED THE VIEWPORT, TESTED THE FUNCTION AND OPERATION OF THE AMSCO 400 STERILIZER, CONFIRMED IT TO BE OPERATING TO SPECIFICATION AND RETURNED THE UNIT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT DURING A CYCLE THEIR AMSCO 400 STERILIZER LEAKED STEAM SUBSEQUENTLY CAUSING THE FACILITY'S FIRE ALARM TO GO OFF. NO REPORT OF INJURY.