GEM FLOW COUPLER DEVICE AND SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT A GEM 3.0 MM FLOW-COUPLER EXPERIENCED RING SEPARATION DURING PHARYNGEAL RECONSTRUCTION FREE FLAP SURGERY AFTER IT HAD BEEN PLACED ON THE PATIENT. THE FLOW-COUPLER RINGS WERE ADEQUATELY REMOVED AND A NEW GEM FLOW-COUPLER WAS USED TO COMPLETE THE ANASTOMOSIS. NO SIGNIFICANT ADDITIONAL ISCHEMIA TIME WAS REPORTED. NO ADVERSE PATIENT OUTCOME WAS REPORTED.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD FOR THIS LOT NUMBER WAS REVIEWED. ONE HUNDRED PERCENT FUNCTIONAL ALIGNMENT TESTING IS PERFORMED ON EACH DEVICE AND 100% VISUAL INSPECTION FOR BROKEN OR MISSING PARTS AND PIN ALIGNMENT IS PERFORMED ON EACH ASSEMBLY DURING THE MANUFACTURING PROCESS. THE RING SEPARATION FORCE IS WITHIN SPECIFICATION. ACCORDING TO THE DEVICE HISTORY RECORD, THE DEVICE MET SPECIFICATION PRIOR TO MARKET RELEASE. THE WING JAW ASSEMBLY AND DOPPLER PROBE WERE RETURNED FOR EVALUATION. THE FLOW-COUPLER RINGS WERE NOT RETURNED. THE DEVICE WAS VISUALLY INSPECTED UNDER 10X-50X MAGNIFICATION. ORGANIC MATERIAL WAS OBSERVED ON THE WING JAW. THE LEFT AND RIGHT WINGS WERE MANUALLY BROUGHT TOGETHER. THE WING JAW ASSEMBLY FUNCTIONED NORMALLY. THE DOPPLER PROBE APPEARED NORMAL. THE DOPPLER PROBE WAS NOT FUNCTIONALLY TESTED. THERE IS NO IMMEDIATE EVIDENCE TO SUPPORT WHY THE RINGS DID NOT STAY TOGETHER. NO ADDITIONAL INFORMATION IS AVAILABLE.