HEXALUX

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 REPLACED 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.

Additional Manufacturer Narrative

INVESTIGATION OF THIS EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR HEXALUX SURGICAL LIGHT DETACHED FROM THE CEILING. USER FACILITY PERSONNEL WOULD NOT PROVIDE INFORMATION REGARDING THE PATIENT WHO WAS PRESENT AT THE TIME OF THE EVENT.