WECK EFX SHIELD PORT SITE CLOSURE SYSTEM

Description of Event or Problem

THE MEDWATCH REPORT STATES "WHEN THE DEVICE WAS DEPLOYED, THE TEAM HEARD A SNAP. THEY EXAMINED THE DEVICE AND THE SIDE PART HAS BROKEN OFF. ANOTHER SIMILAR DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER INCIDENT". ADDITIONAL INFORMATION RECEIVED STATES THAT "THE PATIENT WAS DISCHARGED ALIVE AND IN STABLE CONDITION. NO HARM OR ANY HEALTH CONSEQUENCE. NO MEDICAL INTERVENTION WAS REQUIRED AND NOTHING FELL INTO THE PATIENT'S CAVITY".

Additional Manufacturer Narrative

(B)(4) OTHER REMARKS: N/A CORRECTED DATA: N/A.

Additional Manufacturer Narrative

(B)(4). THE SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER REPORTED: "NO NON-CONFORMANCES RELATED TO THE WING BREAKING WERE NOTED FOR THIS LOT OF MATERIAL. THERE WAS NO CONTAINMENT ACTIVITIES PERFORMED FOR THIS ISSUE AS THIS FAILURE MODE IS INHERENT TO THE DEVICE DESIGN. A REVIEW OF THE DHR FOR THE LOT NUMBER PROVIDED WAS PERFORMED AND THERE WERE NO MANUFACTURING ABNORMALITIES OBSERVED. A REVIEW OF THE MEI SHOWED THAT 100% OF ALL DEVICES MANUFACTURED GO THROUGH TESTING FOR THE APPROXIMATION WING HINGE INTEGRITY AND BOTH SIDES MUST PASS FOR THE DEVICE TO BE CONSIDERED ACCEPTABLE. DEVICES THAT DO NOT PASS BOTH SIDES ARE REJECTED. ADDITIONALLY, ALL SUBSEQUENT FUNCTIONAL TESTING WOULD NOT HAVE BEEN ABLE TO BE PERFORMED. AN EVALUATION OF THE RETURNED UNIT CONFIRMED THE FAILURE MODE OBSERVED BY THE CUSTOMER. SINCE THE DEVICES RECEIVE 100% IN-LINE TESTING FOR BOTH HINGE INTEGRITY AND FUNCTIONAL PERFORMANCE, THE COMPLAINT IS CONSIDERED VERIFIED, BUT NOT A PARAGON MEDICAL FAILURE. FAILURE MODE IS RELATED TO THE DESIGN AND NOT A PARAGON MEDICAL MANUFACTURING OPERATION. WHILE THIS FAILURE MODE HAS BEEN NOTED BEFORE THE FAILURE MODE IS INHERENT TO THE DESIGN AND NOT RELATED TO A PARAGON MEDICAL MANUFACTURING OPERATION." TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

Description of Event or Problem

THE MEDWATCH REPORT STATES "WHEN THE DEVICE WAS DEPLOYED, THE TEAM HEARD A SNAP. THEY EXAMINED THE DEVICE AND THE SIDE PART HAS BROKEN OFF. ANOTHER SIMILAR DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER INCIDENT". ADDITIONAL INFORMATION RECIEVED STATES THAT "THE PATIENT WAS DISCHARGED ALIVE AND IN STABLE CONDITION. NO HARM OR ANY HEALTH CONSEQUENCE. NO MEDICAL INTERVENTION WAS REQURIED AND NOTHING FELL INTO THE PATIENT'S CAVITY".