ENTACT SEPTAL STAPLER 3-PACK

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT AFTER A SEPTOPLASTY PROCEDURE USING ENTACT SEPTAL STAPLER, A PATIENT EXPERIENCED A POST-OPERATIVE SYNECHIAE. NO OTHER COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

H3, H6: THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THERE WAS NO WAY TO DETERMINE IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT. THE COMPLAINT WAS NOT CONFIRMED. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND NO SIMILAR REPORTED EVENTS. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. OUR CLINICAL INVESTIGATION CONCLUDED: BASED ON THE LIMITED INFORMATION PROVIDED A THOROUGH CLINICAL ASSESSMENT CANNOT BE PERFORMED AT THIS TIME. SYNECHIAE IS A KNOWN COMPLICATION THAT CAN OCCUR AFTER NASAL AND SINUS PROCEDURES AND INDEPENDENT OF THE ENTACT STAPLER AND WE CANNOT CONFIRM OR RULE OUT A RELATIONSHIP WITH THE ENTACT STAPLES VERSE SURGICAL CIRCUMSTANCES OR WITH THE PATIENT¿S MEDICAL HISTORY. THERE SHOULD BE NO FURTHER IMPACT TO THE PATIENT BEYOND THE REMOVAL OF THE SYNECHIAE WHICH HAS ALREADY OCCURRED. SHOULD ANY ADDITIONAL CLINICAL INFORMATION BE PROVIDED THIS COMPLAINT WILL BE RE-EVALUATED. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

Additional Manufacturer Narrative

THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW COULD NOT BE CONDUCTED. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND NO SIMILAR REPORTED EVENTS. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A REVIEW OF RISK MANAGEMENT FILES FOUND THAT THERE WAS INSUFFICIENT INFORMATION TO TIE THE REPORTED COMPLAINT TO SPECIFIC LINE ITEMS WITHIN RISK DOCUMENTATION. NO RELEVANT SUPPORTING CLINICAL INFORMATION HAS BEEN PROVIDED TO ASSIST WITH A CLINICAL INVESTIGATION. THEREFORE, BASED ON INSUFFICIENT INFORMATION, A THOROUGH CLINICAL ASSESSMENT CANNOT BE PERFORMED AT THIS TIME. THE PATIENT'S CURRENT CONDITION BEYOND THE REPORTED EVENTS COULD NOT BE DETERMINED BASED ON THE LIMITED INFORMATION PROVIDED. SHOULD ANY ADDITIONAL CLINICAL INFORMATION BE PROVIDED THIS COMPLAINT WILL BE RE-EVALUATED. THERE WAS NO WAY TO DETERMINE IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT. THE COMPLAINT WAS NOT CONFIRMED. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

Additional Manufacturer Narrative

WHEN INITIAL MDR REPORT WAS SUBMITTED, PRODUCT PROBLEM WAS INADVERTENTLY MARKED IN B1, HOWEVER, THERE IS NO REPORT OF PRODUCT MALFUNCTION.

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2021 A SECONDARY RHINOPLASTY FOR AESTHETIC PROBLEMS AND BREATHING PROBLEMS WAS PERFORMED USING ENTACT SEPTAL STAPLE. ON (B)(6), THE PATIENT EXPERIENCED A POST-OPERATIVE SYNECHIAE SO RETURNED TO THE OPERATING ROOM FOR SYNECHIAE REMOVAL. A CONTROL WAS PERFORMED ON DAY 15 WHEN THE RIGHT SEPTUM PLATE WAS REMOVED. THE BREATHING WAS NORMAL. ONE MONTH AFTER THE REVISION SURGERY, THE PATIENT COMPLAINED OF NASAL OBSTRUCTION BUT THERE WAS NO RECURRENCE OF SYNECHIAE. THE PATIENT MUST HAVE A SECOND OPINION IN MONTPELLIER AND WILL CARRY OUT A RHINOMANOMETRY.