VISTEC

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY HAD AN INCIDENT YESTERDAY WHERE THE HEART ROOM OPENED A PACK OF RAYTEC AND THE BLUE XRAY STRANDS WERE MISSING OUT OF ONE OF THE RAYTECS. THE CUSTOMER REPLACED THE RAYTECS WITH A NEW PACK.

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Additional Manufacturer Narrative

SAMPLES WERE NOT RECEIVED FOR THE INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE REPORTED ISSUE AND DETERMINE A ROOT CAUSE. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. IF A SAMPLE IS RECEIVED AT A LATER DATE, THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.