AMSCO 400 STERILIZER
Received Sep 14, 2023
Report 3005899764-2023-00046 · MDR key 17744082
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Product problems
- Use of Device Problem
- Use of Device Problem
Patient
Unknown
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE WAS UNLOADING THEIR AMSCO 400 STERILIZER THE EMPLOYEE OBTAINED A BURN ON THEIR WRIST. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN WAS ONSITE CONDUCTING SERVICE ON ANOTHER UNIT WHEN HE WAS INFORMED THAT AN EMPLOYEE OBTAINED A BURN WHILE UNLOADING A RACK FROM THE STERILIZER. THE TECHNICIAN INSPECTED THE AMSCO 400 STERILIZER AND FOUND THE UNIT TO BE OPERATING PROPERLY. NO ISSUES WITH THE FUNCTION OR THE OPERATION OF THE STERILIZER WERE IDENTIFIED, AND THE STERILIZER WAS RETURNED TO SERVICE. THE AMSCO 400 OPERATOR MANUAL STATES (1-2), "WARNING - BURN HAZARD: STERILIZER, RACK/SHELVES WILL BE HOT AFTER CYCLE IS RUN. ALWAYS WEAR PROTECTIVE GLOVES AND APRON WHEN REMOVING A PROCESSED LOAD. PROTECTIVE GLOVES AND APRON MUST BE WORN WHEN RELOADING STERILIZER FOLLOWING THE PREVIOUS OPERATION." NO ADDITIONAL ISSUES HAVE BEEN REPORTED.