VISTEC

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. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED THAT USED SPONGES WERE THROWN ON TO THE DROP ZONE. THE CIRCULATOR NOTICED WHEN HANGING THEM INTO THE COUNTER BAG, THAT ONE WAS MISSING THE BLUE X RAY STRING. THE AREAS WERE SEARCHED, AND THE CIRCULATOR FOUND THE STRING ON THE FLOOR NEAR THE DROP ZONE. MORE SPONGES WERE EXAMINED AND WERE FOUND TO HAVE THE BLUE DETECTABLE STRING FALLING OUT. ANOTHER SET WAS OPENED WITH THE SAME ISSUE. THE STRING CAN BE EASILY PULLED OUT, THEY COULD BE POTENTIALLY LEFT IN A PATIENT IF THE STRING WOULD BE SEPARATED. PER ADDITIONAL INFORMATION RECEIVED, THERE WAS NO MEDICAL INTERVENTION WAS PERFORMED. IT WAS NOTICED WHEN THE SPONGES WERE REMOVED FROM THE BODY AND THROWN ON TO THE DROP ZONE. ALL SPONGES WERE ACCOUNTED FOR AND REMOVED FROM USAGE.