PLATFORM PREVAC STERILIZER
Received Aug 14, 2025 · Event occurred Jul 15, 2025
Report 3005899764-2025-00069 · MDR key 22803678
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
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 AND LEARNED THAT WHILE THE EMPLOYEE WAS LOADING THE STERILIZER THE LOADING CART HIT THE BOTTOM PANEL, CAUSING THE PANEL TO FALL. THE TECHNICIAN INSPECTED THE UNIT AND FOUND THE SCREWS THAT HOLD THE BOTTOM PANEL WERE LOOSE. THE TECHNICIAN REPLACED THE SCREWS, TESTED THE UNIT AND CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. THE UNIT WAS INSTALLED IN 2013 AND IS APPROXIMATELY 12 YEARS OLD. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. UDI RELATED DATA CLARIFICATION - THE DEVICE SUBJECT OF THE EVENT WAS MANUFACTURED PRIOR TO UDI COMPLIANCE, THEREFORE, UDI IS NOT APPLICABLE AND WAS NOT INCLUDED IN THE MDR.
Description of Event or Problem
THE USER FACILITY REPORTED THAT THE BOTTOM PANEL TO THEIR PLATFORM PREVAC STERILIZER DETACHED AND CONTACTED THE EMPLOYEE'S LEG. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.