AMSCO
Received Dec 19, 2025 · Event occurred Nov 19, 2025
Report 3005899764-2025-00099 · MDR key 23849353
Device
Generic name
Amsco 600 Steam Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 600 STEAM STERILIZERCatalog number
EF1301142
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 TO INSPECT THE UNIT AND FOUND THAT THE JACKET STRAINER WAS BLOCKED, WHICH ALLOWED PRESSURE TO BUILD UP WITHIN THE CHAMBER RESULTING IN THE REPORTED EVENT. TO RESOLVE THE ISSUE, THE TECHNICIAN DEPRESSURIZED THE UNIT AND INSPECTED THE STRAINER, WHICH REVEALED SIGNIFICANT WATER ACCUMULATION. THE TECHNICIAN THEN IDENTIFIED A BLOCKAGE WITHIN THE UNIT'S ELBOW ASSEMBLY. THIS OBSTRUCTION PREVENTED PROPER DRAINAGE, CAUSING AN OVERFLOW THAT RESULTED IN THE REPORTED EVENT. THE TECHNICIAN REPLACED THE ELBOW, TESTED THE UNIT, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT THEIR AMSCO 600 STERILIZER LEAKED STEAM AND WATER ONTO THE FLOOR. NO REPORT OF INJURY.