HEXALUX
Received Aug 26, 2025 · Event occurred Jul 28, 2025
Report 1043572-2025-00080 · MDR key 22897274
Device
Generic name
Hexalux Surgical Light
Manufacturer
Steris CorporationModel number
HEXALUX CEILING MOUNTCatalog number
EXLCEIL
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
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. DURING THE TECHNICIAN'S INSPECTION, HE FOUND THAT THE SLOTTED CONE COMPONENT, WHICH SUPPORTS THE CONNECTION BETWEEN THE SPRING ARM AND DROP TUBE, WAS MISSING. AS A RESULT, THE OTHER COMPONENTS HAD COME LOOSE, RESULTING IN THE REPORTED EVENT. THE TECHNICIAN REPAIRED THE HEXALUX SURGICAL LIGHT AND CONFIRMED ALL COMPONENTS WERE PRESENT AND PROPERLY INSTALLED. THE LIGHTING SYSTEM WAS RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT THEIR HEXALUX SURGICAL LIGHT DETACHED FROM THE CEILING. NO REPORT OF INJURY.