HEXALUX EXAMINATION LIGHT
Received Nov 3, 2023 · Event occurred Oct 5, 2023
Report 3011221111-2023-00003 · MDR key 18067708
Device
Generic name
Examination Light
Manufacturer
Steris SasModel number
HEXALUX CEILING MOUNTCatalog number
EXLCEIL
Product problems
- Installation-Related Problem
- Installation-Related Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT THE SPRING ARM ON THEIR HEXALUX EXAMINATION LIGHT DETACHED AT THE END OF A PATIENT PROCEDURE. NO REPORT OF INJURY OR PROCEDURE DELAY.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE LIGHTING SYSTEM AND FOUND THAT THE EXAMINATION LIGHT WAS IMPROPERLY INSTALLED. AS A RESULT OF IMPROPER INSTALLATION, THE RETAINING RING BECAME LOOSE CAUSING THE SPRING ARM TO DETACH. THE SUBCONTRACTOR RESPONSIBLE FOR INSTALLATION WAS RETRAINED ON THE PROPER INSTALLATION PROCEDURE. THE TECHNICIAN REINSTALLED THE LIGHTING SYSTEM, TESTED IT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. AS A PRECAUTIONARY MEASURE, THE TECHNICIAN INSPECTED ALL THE OTHER HEXALUX LIGHTING SYSTEMS AT THE USER FACILITY TO CONFIRM PROPER INSTALLATION AND OPERATION. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.