AMSCO
Received Nov 13, 2025 · Event occurred Oct 15, 2025
Report 3005899764-2025-00088 · MDR key 23544742
Device
Generic name
Amsco 400 Steam Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 400 STEAM STERILIZERCatalog number
SR0101110311
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND NO ISSUES WITH THE FUNCTION OR OPERATION. THE UNIT WAS CONFIRMED TO BE OPERATING TO SPECIFICATIONS, AND THE REPORTED EVENT COULD NOT BE DUPLICATED. THE OPERATOR MANUAL STATES (PG.45), "STEAM MAY BE RELEASED FROM THE CHAMBER WHEN DOOR IS OPENED. STEP BACK FROM THE STERILIZER EACH TIME THE DOOR IS OPENED TO MINIMIZE CONTACT WITH STEAM VAPOR." THE TECHNICIAN PROACTIVELY REBUILT THE S2 VALVE, TESTED THE UNIT AND CONFIRMED IT TO BE OPERATING PROPERLY. THE AMSCO 400 STERILIZER WAS RETURNED TO SERVICE, AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE RECEIVED A STEAM "BURN" TO THE BACK OF THEIR HAND WHILE OPENING THEIR AMSCO 400 STERILIZER DOOR AND REACHING FOR THE CYCLE PRINTOUT TAPE. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED AND THE EMPLOYEE CONTINUED WORKING.