GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE RINGS OF TWO (2) 3.0MM COUPLERS FELL OUT OF THE WING WITHOUT ANY SIGNIFICANT PRESSURE. THIS WAS OBSERVED WHILE INSERTING THE COUPLER INTO THE "RIGHT RING" WHILE HOLDING THE DEVICE BY HAND DURING AN INTRA-OPERATION STEP. ANOTHER ATTEMPT WAS MADE TO INSERT FROM THE TIP; HOWEVER, WAS LOOSE AND FELL OUT AGAIN. THE ISSUE WAS RESOLVED BY CHANGING THE SIZE TO A 2.5MM COUPLER. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO D9, H3, AND H6. H11: TWO (2) ACTUAL DEVICES AND A COMPANION SAMPLE WERE RECEIVED FOR EVALUATION. THE FIRST 3.0MM COUPLER JAW WAS RETURNED WITH THE LEFT RING SEATED IN THE JAW ASSEMBLY. DURING VISUAL INSPECTION, NO SIGNS OF USE WERE VISIBLE SUCH AS DRIED BLOOD WHICH IS NOT CONSISTENT WITH THE COMPLAINANT¿S STATEMENT THAT THE EVENT OCCURRED DURING THE SURGICAL PROCESS. IT IS UNKNOWN IF THE RETURNED PRODUCT WAS CLEANED PRIOR TO RETURN FOR INVESTIGATION. THE RIGHT RING WAS NO LONGER PRESENT IN THE JAW ASSEMBLY. DURING THE FUNCTIONAL INVESTIGATION, THE JAW ASSEMBLY WAS CLICKED INTO THE ANASTOMOTIC INSTRUMENT (AI) AS INTENDED. THE KNOB OF THE AI WAS ROTATED TO ENSURE THE JAW ASSEMBLY WOULD FUNCTION AS INTENDED WITHIN THE SURGICAL PROCESS. THERE WERE NO OBSERVED FUNCTIONAL MALFUNCTIONS WITH THE JAW ASSEMBLY. IT IS UNKNOWN IF ANY PORTION OF THE PREPARATION FOR USE OF THE COUPLER PRODUCT OR USE OF THE PRODUCT IN THE SURGICAL PROCESS MAY HAVE CONTRIBUTED TO THE ALLEGED DEFECT. THE SECOND 3.0MM COUPLER JAW ASSEMBLY WAS RETURNED WITH BOTH RINGS NO LONGER SEATED IN THE JAW ASSEMBLY. DURING VISUAL INSPECTION, NO SIGNS OF USE WERE VISIBLE SUCH AS DRIED BLOOD WHICH IS NOT CONSISTENT WITH THE COMPLAINANT¿S STATEMENT THAT THE EVENT OCCURRED DURING USE. IT IS UNKNOWN IF THE RETURNED PRODUCT WAS CLEANED PRIOR TO RETURN FOR INVESTIGATION. DURING THE FUNCTIONAL INVESTIGATION, THE JAW ASSEMBLY WAS CLICKED INTO THE ANASTOMOTIC INSTRUMENT (AI) AS INTENDED. THE KNOB OF THE AI WAS ROTATED TO ENSURE THE JAW ASSEMBLY WOULD FUNCTION AS INTENDED WITHIN THE SURGICAL PROCESS. THERE WERE NO OBSERVED FUNCTIONAL MALFUNCTIONS WITH THE JAW ASSEMBLY. IT IS UNKNOWN IF ANY PORTION OF THE PREPARATION FOR USE OF THE COUPLER PRODUCT OR USE OF THE PRODUCT IN THE SURGICAL PROCESS MAY HAVE CONTRIBUTED TO THE ALLEGED DEFECT. WHILE IT CANNOT BE COMPLETELY RULED OUT, IT IS UNLIKELY THAT THE MANUFACTURING OF THE PRODUCT CONTRIBUTED TO THE ALLEGATIONS AS NO DEFECT COULD BE FOUND WITH THE RETURNED 3.0MM COUPLER PRODUCT. THE 3.0MM COUPLER JAW ASSEMBLY COMPANION SAMPLE THAT WAS RETURNED FOR INVESTIGATION WAS SEALED IN ITS ORIGINAL PACKAGING. UPON INVESTIGATION, THE COMPANION SAMPLE OF THE 3.0MM COUPLER JAW ASSEMBLY WAS CLICKED INTO THE ANASTOMOTIC INSTRUMENT AND BROUGHT TOGETHER. THE RINGS ALIGNED AS INTENDED WHEN APPROXIMATED. THE COMPANION SAMPLE THAT WAS SENT FOR INVESTIGATION MET ALL FINISHED GOOD REQUIREMENTS AND FUNCTIONED AS INTENDED. WHILE IT CAN BE ASSUMED THAT THE COMPLAINT PRODUCT ALSO FUNCTIONED, DEVICE MALFUNCTION CANNOT BE FULLY DETERMINED AS PART OF THIS INVESTIGATION. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.