WECK EFX SHIELD PORT SITE CLOSURE SYSTEM

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT "WHILE THE SURGEON WAS TRIALING THE WECK SHIELD FOR THE SECOND TIME DURING A LAPAROSCOPIC CHOLECYSTECTOMY CASE, AND I WAS PROVIDING GUIDANCE IN THE CASE, THE SHIELD PASSER/GRASPER WOULD NOT CAPTURE THE SUTURE AFTER SUCCESSFULLY CAPTURING THE FIRST SIDE OF THE SUTURE WITHOUT ISSUE. UPON INSPECTION OF THE PASSER, IT APPEARED THAT THE HOOK WAS MISSING OR BROKEN TO AN EXTENT THAT IT WOULD NOT PUSH FORWARD OR DEPLOY WHEN PRESSURE WAS APPLIED TO FORCE THE HOOK OUT OF THE PASSER SHAFT TO RETRIEVE THE SUTURE." NO PATIENT INJURY OR CONSEQUENCE REPORTED, NO MEDICAL INTERVENTION REQUIRED. THE PATIENT STATUS IS REPORTED AS "FINE."

Additional Manufacturer Narrative

(B)(4). THE SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER REPORTED: "A REVIEW OF THE DEVICE CONFIRMED THAT THE DEVICE WAS NOT FUNCTIONAL AS DESCRIBED IN THE NOTIFICATION SUMMARY. HOWEVER, THE NOTIFICATION SUMMARY INDICATED THAT THE DEVICE OPERATED CORRECTLY AT THE BEGINNING OF THE PROCEDURE. A REVIEW OF THIS NOTIFICATION SUMMARY WITH THE ENGINEERING TECHNICIAN FOR THE EFX002 PRODUCTION LINE NOTED THAT, WHILE NOT A COMMON FAILURE MODE, HE HAD EXPERIENCED INSTANCES WHERE THE DEVICE COULD BE MANUFACTURED AND TESTED CORRECTLY AND THE SPRING WILL BECOME DISLODGED FROM ITS CORRECT POSITION. SINCE THE PRODUCT IS TESTED 00% AND THE DEVICE WORKED FOR THE FIRST SUTURE, IT CAN BE PRESUMED THAT THIS IS WHAT OCCURRED. THEREFORE, THIS COMPLAINT IS CONSIDERED VERIFIED, BUT NOT A VALID MANUFACTURING ERROR. A REVIEW OF THE DHR SHOWED THAT THERE WERE NO NONCONFORMANCES NOTED. A REVIEW OF THE DHR SHOWED THAT THERE WERE NO MANUFACTURING ABNORMALITIES OBSERVED OR NOTED. ALL LOTS RECEIVE 100% FUNCTIONAL TESTING IN-PROCESS TO ENSURE THE GRASPER CAN LATCH ONTO THE SUTURE, THEREFORE THERE ARE NO ADDITIONAL CONTAINMENT ACTIVITIES REQUIRED. A REVIEW OF THE MEI SHOWED THAT THE MANUFACTURING INSTRUCTIONS CONTAIN ADEQUATE DETAIL FOR PERFORMING THE FUNCTIONAL TEST. A DISCUSSION WITH THE OPERATORS INDICATED THAT THE TEST IS BEING PERFORMED AS DIRECTED WITHIN THE MEI." TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

Description of Event or Problem

IT WAS REPORTED THAT "WHILE THE SURGEON WAS TRIALING THE WECK SHIELD FOR THE SECOND TIME DURING A LAPAROSCOPIC CHOLECYSTECTOMY CASE, AND I WAS PROVIDING GUIDANCE IN THE CASE, THE SHIELD PASSER/GRASPER WOULD NOT CAPTURE THE SUTURE AFTER SUCCESSFULLY CAPTURING THE FIRST SIDE OF THE SUTURE WITHOUT ISSUE. UPON INSPECTION OF THE PASSER, IT APPEARED THAT THE HOOK WAS MISSING OR BROKEN TO AN EXTENT THAT IT WOULD NOT PUSH FORWARD OR DEPLOY WHEN PRESSURE WAS APPLIED TO FORCE THE HOOK OUT OF THE PASSER SHAFT TO RETRIEVE THE SUTURE." NO PATIENT INJURY OR CONSEQUENCE REPORTED, NO MEDICAL INTERVENTION REQUIRED. THE PATIENT STATUS IS REPORTED AS "FINE."