PLATFORM STERILIZER
Received Oct 25, 2023 · Event occurred Sep 28, 2023
Report 3005899764-2023-00056 · MDR key 18006897
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
- Bruise/Contusion
- Bruise/Contusion
Narrative
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.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT AND FOUND THAT THE CHAIN THAT SECURES THE LOWER ACCESS PANEL TO THE UNIT HAD DETACHED. THE TECHNICIAN RE-ATTACHED AND SECURED THE CHAIN TO THE UNIT. THE TECHNICIAN ALSO RE-SECURED THE MAGNET BRACKETS AND SCREWS THAT ALSO SECURE THE LOWER ACCESS PANEL TO THE UNIT. THE UNIT WAS TESTED AND RETURNED TO SERVICE. THE UNIT WAS APPROXIMATELY FIFTEEN YEARS OLD AT THE TIME OF THE REPORTED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT THE ACCESS PANEL LOCATED AT THE BOTTOM OF THEIR PLATFORM STERILIZER FELL AND CONTACTED AN EMPLOYEE'S FOOT RESULTING IN A BRUISE. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.