HEXALUX

Additional Manufacturer Narrative

THE TECHNICIAN REPLACED THE UNIT'S RETAINING RING AND REINSTALLED THE HEXALUX EXAMINATION LIGHT. THE TECHNICIAN TESTED THE LIGHTING SYSTEM, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR HEXALUX EXAMINATION LIGHT PARTIALLY DETACHED WHILE BEING REPOSITIONED, CONTACTING BOTH A PATIENT AND A USER FACILITY EMPLOYEE. IT WAS REPORTED THAT BOTH THE PATIENT AND USER FACILITY EMPLOYEE WERE INJURED; HOWEVER, THE EXTENT OF THE ALLEGED INJURIES, OR ANY RESULTING MEDICAL TREATMENT HAS NOT BEEN PROVIDED.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE LIGHT. BASED ON THE COMPONENTS PRESENT DURING THE TECHNICIAN'S INSPECTION, IT WAS CONCLUDED THAT A COMPONENT PART MAY HAVE BEEN INADVERTENTLY OMITTED DURING INSTALLATION OF THE LIGHT. AS A RESULT, THE RETAINING RING BECAME LOOSE CAUSING THE SPRING ARM TO DETACH. THE TECHNICIAN RESPONSIBLE FOR INSTALLATION WAS RETRAINED ON THE PROPER INSTALLATION PROCEDURE. THE LIGHT HAS BEEN REMOVED FROM SERVICE PENDING REINSTALLATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.