HEXALUX

Additional Manufacturer Narrative

A STERIS SERVICE INSTALLATION SPECIALIST ARRIVED ONSITE TO INSPECT THE HEXALUX CEILING-MOUNTED SURGICAL LIGHT. THE TECHNICIAN IDENTIFIED THE CAUSE OF THE REPORTED EVENT TO BE THE SNAP RING THAT SECURES THE LIGHT'S SUSPENSION ARM TO THE CEILING MOUNT HAD BEEN DAMAGED. THE CAUSE OF THE DAMAGE COULD NOT BE DETERMINED. AS THE SNAP RING WAS DAMAGED, OVER TIME, THIS ALLOWED FOR THE LIGHT'S SUSPENSION ARM TO LOOSEN AND EVENTUALLY DETACH, RESULTING IN THE REPORTED EVENT. THE USER FACILITY ELECTED TO HAVE THEIR HEXALUX CEILING-MOUNTED SURGICAL LIGHT REMOVED FROM SERVICE AND NOT REPAIRED OR REPLACED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR HEXALUX EXAMINATION LIGHT DETACHED FROM THE CEILING. NO REPORT OF INJURY.

Additional Manufacturer Narrative

OUR INVESTIGATION INTO THE REPORTED EVENT IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. UDI RELATED DATA CLARIFICATION - THE LOT/SERIAL NUMBER IS UNKNOWN; THEREFORE, THE APPLICABLE PRODUCTION IDENTIFIERS WERE NOT INCLUDED IN THE MDR.