AMSCO
Received Feb 12, 2025 · Event occurred Jan 13, 2025
Report 3005899764-2025-00013 · MDR key 21367383
Device
Generic name
Amsco C Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
16CCatalog number
RR01
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Eye Infections
- Eye Infections
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE STERILIZER. WHILE ONSITE, THE USER FACILITY DECLINED INSPECTION OF THEIR UNIT STATING THAT THE STERILIZER WAS OPERATIONAL WITH NO ISSUES NOTED. AS THE EQUIPMENT COULD NOT BE INSPECTED, AN EXACT ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Additional Manufacturer Narrative
INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. A STERIS SERVICE TECHNICIAN IS WORKING WITH THE USER FACILITY TO SCHEDULE A TIME TO INSPECT THE UNIT SUBJECT OF THE REPORTED EVENT. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE USER FACILITY CONTACTED STERIS REQUESTING FUNCTIONAL TESTING OF THEIR AMSCO C STERILIZER FOLLOWING A REPORT OF A PATIENT INFECTION.