AMSCO V-PRO
Received May 28, 2026 · Event occurred Apr 28, 2026
Report 3005899764-2026-00041 · MDR key 25315521
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Product problems
- Smoking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND THAT THE CARTRIDGE FILTER O-RING WAS NOT SEALED. THIS CAUSED VAPOR (NOT SMOKE) TO BYPASS THE CARTRIDGE FILTERS, SUBSEQUENTLY CAUSING THE REPORTED EVENT. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE CARTRIDGE FILTERS. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. 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 "SMOKE" EMITTED FROM THEIR V-PRO MAX STERILIZER. NO REPORT OF INJURY.