GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3, H6, H11. H11: THE DEVICE WAS RECEIVED FOR EVALUATION. THE 2.5MM COUPLER JAW ASSEMBLY WAS RETURNED IN THE COUPLER TRAY. THE RINGS WERE NO LONGER INTACT IN THE JAW ASSEMBLY. UPON VISUAL INSPECTION, SIGNS OF USE WERE VISIBLE ON THE COUPLER RINGS, SUCH AS DRIED BLOOD IN THE MATING HOLES. THIS IS NOT CONSISTENT WITH THE COMPLAINANT¿S STATEMENT THAT THE ALLEGED EVENT OCCURRED PRIOR TO USE. THE RETURNED JAW ASSEMBLY WAS CLICKED INTO THE ANASTOMOTIC INSTRUMENT (AI) TO DETERMINE IF ANY DEFECTS WERE PRESENT THAT MAY HAVE CONTRIBUTED TO THE ALLEGED EVENT OF RING DISLODGEMENT. THE AI KNOB WAS THEN TURNED AS IT WOULD BE IN SURGICAL PROCESS TO SIMULATE APPROXIMATING THE RINGS. THERE APPEARED TO BE NO DEFECT IN ANY PORTION OF THE JAW ASSEMBLY. THE PRODUCT RETURNED FOR THE INVESTIGATION, AND THE INVESTIGATION ITSELF, DOES NOT ALIGN WITH THE ALLEGATION THAT THE PRODUCT ¿RING FALL ITSELF BEFORE USE¿ AS THE CUSTOMER STATED. HOWEVER, THIS COMPLAINT WILL BE CONSERVATIVELY CONFIRMED FOR RING DISLODGEMENT AS THE RETURNED RINGS WERE NO LONGER INTACT IN THE JAW ASSEMBLY. THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

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 RING OF A 2.5MM COUPLER FELL OUT OF THE JAW ASSEMBLY; FURTHER DESCRIBED AS "RING FALL ITSELF". THIS WAS OBSERVED BEFORE USING THE DEVICE IN AN OPERATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.