AMSCO
Received Dec 13, 2024 · Event occurred Nov 13, 2024
Report 3005899764-2024-00072 · MDR key 20924041
Device
Generic name
Amsco 600 Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AMSCO 600 STEAM STERILIZERCatalog number
EF1101222
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 TO INSPECT THE UNIT AND FOUND THAT THE STEAM GENERATOR WAS OVER FILLING WITH WATER. AS DESIGNED, THE SAFETY VALVE OPENED, AND EXCESS STEAM EMITTED FROM THE UNIT. UPON FURTHER INSPECTION, THE TECHNICIAN FOUND THAT THE GENERATOR CHECK VALVE REQUIRED REPLACEMENT. THE TECHNICIAN SHUT THE WATER OFF AND FOUND THAT DEBRIS WAS STUCK IN THE GENERATOR CHECK VALVE. THE SOURCE OR CONTENTS OF THE DEBRIS COULD NOT BE DETERMINED. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE CHECK VALVE, AND CLEANED THE PIPING. THE TECHNICIAN TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATIONS AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Additional Manufacturer Narrative
INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS; A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE USER FACILITY REPORTED STEAM LEAKING FROM THEIR AMSCO 600 STERILIZER. THERE WAS REPORT OF PROCEDURE DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY THE SAME DAY. NO REPORT OF INJURY.