ENTACT SEPTAL STAPLER, 1-PACKSEPTAL STAPLER/ABSORBABLE STAPLES

Description of Event or Problem

IT WAS REPORTED THAT A 1 MM POST-OPERATIVE PERFORATION OCCURRED IN 1 PATIENT DUE TO JAMMING OF THE ENTACT SEPTAL STAPLER.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE CANNOT DETERMINE IF THERE IS A RELATIONSHIP BETWEEN THE DEVICE AND THE INCIDENT BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE THE DEVICE IN QUESTION WAS NOT RETURNED FOR EVALUATION. THUS, THE COMPLAINT COULD NOT BE VERIFIED AND A ROOT CAUSE COULD NOT BE DETERMINED WITH CONFIDENCE. SEVERAL FACTORS COULD TRIBUTE TO THE REPORTED COMPLAINT. IT IS POSSIBLE THAT EXCESSIVE BLOOD OR TISSUE COULD JAM THE STAPLES IN THE BLOCK, THE IMPLANTS COULD HAVE BEEN MISALIGNED WITHIN THE HOLDING BLOCK OR THAT THE IMPLANTS WERE NOT PROPERLY SET ORIGINALLY.