HEXALUX EXAMINATION LIGHT

Additional Manufacturer Narrative

THE TECHNICIAN REPAIRED THE LIGHTING SYSTEM, TESTED THE FUNCTION AND OPERATION, AND CONFIRMED THE LIGHTING SYSTEM TO BE OPERATING ACCORDING TO SPECIFICATION. THE TECHNICIAN PERFORMED AN INSPECTION OF ALL THE USER FACILITY'S HEXALUX LIGHTING SYSTEMS AND FOUND THEM TO BE PROPERLY INSTALLED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

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 THREADED PINS WAS NOT FULLY INSERTED IN THE SPINDLE RESULTING IN THE REPORTED EVENT. THE TECHNICIAN IS AWAITING PARTS TO MAKE THE NECESSARY REPAIRS. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR HEXALUX EXAMINATION LIGHT CAME DOWN FROM THE CEILING CONTACTING AN EMPLOYEE'S BACK. THE UNIT DID NOT COMPLETELY DETACH FROM THE CEILING AS THE ELECTRICAL CABLE WAS STILL INTACT. NO REPORT OF INJURY OR PROCEDURE DELAY.