HEXALUX

Additional Manufacturer Narrative

THE TECHNICIAN INSTALLED THE NEW HEXALUX SURGICAL LIGHT. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND PLACED INTO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR HEXALUX SURGICAL LIGHT DETACHED FROM THE CEILING AND CONTACTED A PATIENT'S SHOULDER. MEDICAL TREATMENT ADMINISTERED (X-RAYS). NO REPORT OF INJURY.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT. THE UNIT HAD BEEN REMOVED FROM THE ROOM AND PLACED ON A CART BY USER FACILITY PERSONNEL PRIOR TO THE TECHNICIAN'S ARRIVAL. DURING THE INSPECTION, THE TECHNICIAN FOUND THAT SEVERAL COMPONENTS WERE MISSING. THE MISSING COMPONENTS MAY HAVE BEEN DISCARDED BY USER FACILITY PERSONNEL FOLLOWING THE EVENT. AN EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS THE COMPONENTS WERE NOT AVAILABLE FOR EVALUATION. THE UNIT IS BEING REPLACED WITH A NEW HEXALUX SURGICAL LIGHT. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.