ENTACT SEPTAL STAPLER, 3-PACK

Description of Event or Problem

IT WAS REPORTED THAT PATIENT PRESENTED ABNORMAL SWELLING AFTER PROCEDURE. DESPITE SEVERAL ATTEMPTS TO GET MORE INFORMATION REGARDING PATIENT CONDITION, NO RESPONSE HAS BEEN RECEIVED FROM REPORTER.

Additional Manufacturer Narrative

THE REPORTED DEVICE, USED FOR TREATMENT, 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. THERE ARE SEVERAL FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT AND ARE OUTLINED IN THE IFU SUCH AS: DO NOT USE IN PATIENTS IN WHOM PROLONGED TISSUE APPROXIMATION BEYOND THAT NEEDED FOR NORMAL TISSUE CLOSURE IS NECESSARY OR DESIRED. AS WITH ANY SURGICAL PROCEDURE, CARE SHOULD BE EXERCISED IN TREATING INDIVIDUALS WITH PREEXISTING CONDITIONS THAT MAY AFFECT THE SUCCESS OF THE SURGICAL PROCEDURE. PLACEMENT OF SUPPORTING SUTURES OR OTHER CLOSURE AUGMENTATION MAY BE REQUIRED TO ENSURE CLOSURE INTEGRITY WHEN EXCESSIVE TENSION ON THE WOUND EDGE IS OR MAY BE PRESENT, E.G. HIGH-TENSION AREAS, EXCISIONS, OR WOUNDS THAT MAY EXPERIENCE SIGNIFICANT SWELLING. PREOPERATIVE AND OPERATIVE PROCEDURES, INCLUDING PROPER PATIENT SELECTION, KNOWLEDGE OF TECHNIQUES, AND PROPER DEVICE SELECTION ARE IMPORTANT CONSIDERATIONS WHEN USING THE DEVICE.