inforMED
MalfunctionFLE

NA

Received Sep 26, 2025 · Event occurred Aug 22, 2025

Report 3005899764-2025-00081 · MDR key 23155379

Device

Generic name

Loading Car

Model number

15966-02

Catalog 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.