HEXALUX EXAMINATION LIGHT

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROCESS, A FOLLOW-UP MDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THE LIGHT SPRING ARM TO THEIR HEXALUX EXAMINATION LIGHT DETACHED. THE PATIENT WAS NOT PRESENT IN THE ROOM DURING THE TIME OF THE EVENT. NO REPORT OF INJURY.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE LIGHTING SYSTEM AND FOUND THAT ONE OF THE COMPONENTS THAT HELPS SUPPORT THE LIGHTING SYSTEM AND KEEP THE RETAINING RING IN PLACE WAS NOT INSTALLED PROPERLY. THE RETAINING RING THEN LOOSENED WHICH CAUSED THE REPORTED EVENT. AN INVESTIGATION REVEALED THAT THE ORIGINAL INSTALLATION TECHNICIAN DID NOT PROPERLY INSTALL THE LIGHT; THIS EMPLOYEE WAS RETRAINED ON THE PROPER INSTALLATION TECHNIQUE. THE SERVICE TECHNICIAN REPLACED THE LIGHT, TESTED IT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. THE TECHNICIAN INSPECTED ALL OTHER LIGHTING SYSTEMS AT THE USER FACILITY. ALL WERE CONFIRMED TO BE PROPERLY INSTALLED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.