AMSCO
Received Jun 18, 2026 · Event occurred May 13, 2026
Report 3005899764-2026-00043 · MDR key 25552946
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 400 STEAM STERILIZERCatalog number
SR2121213011
Product problems
- Mechanical Problem
Patient
NA · Unknown
- Burn(s)
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT AND FOUND THAT WHEN THE AMSCO 400 STERILIZER DOOR WAS POSITIONED HALF OPEN IT WOULD DRIFT CLOSED. THE DRIFTING OF THE DOOR RESULTED IN THE REPORTED EVENT. THE TECHNICIAN FURTHER FOUND THAT THE DOOR HINGES REQUIRED REPLACEMENT. THE TECHNICIAN REPLACED THE DOOR HINGES, TESTED THE FUNCTION AND OPERATION OF THE AMSCO 400 STERILIZER, CONFIRMED THE UNIT TO BE OPERATING TO SPECIFICATIONS AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN TO HER ARM WHILE REMOVING AN ITEM SHE HAD PLACED INTO THEIR AMSCO 400 STERILIZER. THE EMPLOYEE SOUGHT AND RECEIVED MEDICAL TREATMENT.