PLATFORM PREVAC STERILIZER
Received Dec 12, 2024 · Event occurred Nov 15, 2024
Report 3005899764-2024-00071 · MDR key 20918662
Device
Generic name
Platform Prevac Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Laceration(s)
- Laceration(s)
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A SMALL CUT AFTER HITTING THEIR HEAD ON THE DOOR OF THEIR PLATFORM PREVAC STERILIZER. THE EMPLOYEE DID NOT SEEK MEDICAL TREATMENT AND CONTINUED WORKING.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND DISCOVERED THAT THE DOOR SEAL OF THE UNIT PULLED OUT FROM THE BOTTOM OF THE STERILIZER AND WAS STUCK TO THE BOTTOM OF THE DOOR. THE EMPLOYEE ATTEMPTED TO REINSERT THE SEAL AND UPON STANDING UP, HIT THEIR HEAD ON THE EDGE OF THE STERILIZER SUBSEQUENTLY CAUSING THE REPORTED EVENT. WHILE ONSITE, THE TECHNICIAN WAS UNABLE TO DETERMINE A ROOT CAUSE FOR THE SEAL BECOMING STUCK TO THE DOOR. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. A 3-YEAR COMPLAINT REVIEW DETERMINED THIS TO BE AN ISOLATED EVENT. 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.