N/A
Received Jan 3, 2025 · Event occurred Dec 6, 2024
Report 3005899764-2025-00002 · MDR key 21074140
Device
Generic name
Loading Car
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AX082010001Catalog number
AX082010001
Product problems
- Sharp Edges
- Sharp Edges
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 TO INSPECT THE EVOLUTION LOADING CARS (SERIAL NUMBERS (B)(6). THE TECHNICIAN IDENTIFIED "SHARP" EDGES ON THE LOADING CARS' SHELF. THE LOADING CARS OF THE REPORTED EVENT HAVE BEEN REMOVED FROM SERVICE AND AWAITING REPLACEMENTS. A FOLLOW-UP MDR WILL BE SUBMITTED ONCE NEW INFORMATION BECOMES AVAILABLE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT THEIR EVOLUTION LOADING CARS HAD SHARP EDGES WHICH ARE SNAGGING AND TEARING HOLES IN THEIR SURGICAL PACKS. A PROCEDURE DELAY WAS REPORTED AS USER FACILITY PERSONNEL ELECTED TO REPROCESS INSTRUMENTS. NO REPORT OF INJURY.
Additional Manufacturer Narrative
THE USER FACILITY HAS RECEIVED NEW SHELVES. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.