AMSCO 400 STERILIZER
Received Oct 5, 2023 · Event occurred Sep 11, 2023
Report 3005899764-2023-00049 · MDR key 17875916
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.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 CK5 BOLT AND GASKET ON THE WATER MANIFOLD WAS DAMAGED ALLOWING WATER TO LEAK FROM THE UNIT. THE AMSCO 400 STERILIZER SUBJECT OF THE REPORTED EVENT WAS MANUFACTURED IN 2014 AND WAS APPROXIMATELY NINE YEARS OLD AT THE TIME OF THE REPORTED EVENT. THE USER FACILITY ELECTED TO HAVE THE UNIT DEINSTALLED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR AMSCO 400 STERILIZER ONTO THE FLOOR. NO REPORT OF INJURY. REPORT OF PROCEDURE CANCELLATIONS.
Additional Manufacturer Narrative
UDI RELATED DATA QUALITY UPDATES ONLY: THE DEVICE SUBJECT OF THE EVENT WAS MANUFACTURED PRIOR TO UDI COMPLIANCE; THEREFORE, UDI IS NOT APPLICABLE AND WAS NOT INCLUDED IN THE MDR.