NA
Received Sep 26, 2025 · Event occurred Aug 22, 2025
Report 3005899764-2025-00081 · MDR key 23155379
Device
Generic name
Loading Car
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
15966-02Catalog number
1596602
Product problems
- Sharp Edges
- Sharp Edges
Patient
NA · Unknown
- Laceration(s)
- Laceration(s)
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT EMPLOYEES ARE OBTAINING "LACERATIONS" TO THEIR HANDS WHILE UTILIZING THEIR LOADING CAR. IT IS UNKNOWN IF THE EMPLOYEES SOUGHT OR RECEIVED MEDICAL TREATMENT.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE LOADING CAR AND FOUND THE DEVICE TO HAVE ROUGH EDGES. THE TECHNICIAN SMOOTHED DOWN THE ROUGH EDGES AND RETURNED THE UNIT TO SERVICE. A 2-YEAR COMPLAINT REVIEW WAS PERFORMED AND CONFIRMED THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.