HEXALUX EXAMINATION LIGHT
Received Oct 7, 2021 · Event occurred Sep 10, 2021
Report 3011221111-2021-00003 · MDR key 12594480
Device
Generic name
Examination Light
Manufacturer
Steris SasProduct problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Not reported
- 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 LIGHTING SYSTEM AND CONFIRMED THAT THE LIGHT HEAD AND SPRING ARM HAD DETACHED FROM THE CEILING MOUNT. THE TECHNICIAN FOUND THAT ONE OF THE SCREWS THAT CONNECTS THE INNER TUBE TO THE DROP TUBE WAS MISSING. AS THE SCREW WAS MISSING, THIS ALLOWED FOR THE INNER TUBE TO SLIP OUT OF THE DROP TUBE RESULTING IN THE REPORTED EVENT. A COMPLAINT REVIEW INDICATES THIS TO BE AN ISOLATED EVENT. THE TECHNICIAN MADE THE NECESSARY REPAIRS, TESTED THE UNIT, CONFIRMED IT WAS OPERATING ACCORDING TO SPECIFICATION AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT WHILE A PATIENT WAS IN AN EMERGENCY ROOM THE LIGHT HEAD AND SPRING ARM ON THEIR HEXALUX EXAMINATION LIGHT DETACHED AND WAS HANGING BY THE WIRING WITHIN THE LIGHT. NO REPORT OF INJURY OR PROCEDURE DELAY.