AMSCO
Received Dec 23, 2024 · Event occurred Nov 26, 2024
Report 3005899764-2024-00078 · MDR key 21006174
Device
Generic name
Amsco 600 Steam Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 600 STEAM STERILIZERCatalog number
EF1101142
Product problems
- Leak/Splash
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT THEIR AMSCO 600 STERILIZER WAS LEAKING WATER ONTO THE FLOOR. NO REPORT OF INJURY.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN INSPECTED THE AMSCO 600 STERILIZER AND FOUND THAT THE LEAK WAS COMING FROM THE SIGHT GLASS. UPON FURTHER INSPECTION, THE TECHNICIAN FOUND THAT THE SEAL WITHIN THE SIGHT GLASS WAS DAMAGED. THE TECHNICIAN ORDERED PARTS TO REPLACE THE SIGHT GLASS ASSEMBLY. THE UNIT HAS BEEN REMOVED FROM SERVICE PENDING REPAIRS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN INSPECTED THE AMSCO 600 STERILIZER AND FOUND THAT THE LEAK WAS COMING FROM THE SIGHT GLASS DUE TO A DAMAGED GASKET. TO RESOLVE THE ISSUE, THE TECHNICIAN REPAIRED THE SIGHT GLASS, TESTED THE UNIT, FOUND IT TO BE OPERATING TO SPECIFICATION, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.