GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION; THE COUPLER RINGS, JAW ASSEMBLY, AND WHITE PROTECTIVE HOLDER WAS RETURNED IN THE INNER TRAY OF THE COUPLER PACKAGING. VISUAL INSPECTION IDENTIFIED SIGNS OF USE (DRIED BLOOD AND TISSUE). VISUAL INSPECTION OF THE RETURNED JAW ASSEMBLY AND WHITE PROTECTIVE HOLDER SHOWED THAT NO DAMAGE WAS PRESENT THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. VISUAL INSPECTION OF THE COUPLER RINGS IDENTIFIED MISALIGNMENT IN THE APPROXIMATED RINGS. A MISALIGNMENT HAPPENS WHEN THE PINS ON THE COUPLER RING ARE NOT PROPERLY ALIGNED WITH THE MATING HOLES ON THE OPPOSING RING. THE VISIBLE MISALIGNMENT WOULD NOT ALLOW FOR THE PROCESS TO BE COMPLETED SUCCESSFULLY. IF EITHER COUPLER RING HAD BEEN PARTIALLY DISLODGED FROM THE JAW ASSEMBLY IN PREPARATION FOR OR DURING THE SURGICAL PROCESS, A MISALIGNMENT OF THE COUPLER RINGS IS POSSIBLE. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE RING MISALIGNMENT 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.

Description of Event or Problem

IT WAS REPORTED THAT THE RING OF A 3.5MM COUPLER FELL OFF IMMEDIATELY AFTER THE REMOVAL OF THE WHITE CAP. THIS OCCURRED AFTER THE COUPLER WAS ATTACHED TO THE ANASTOMOTIC INSTRUMENT; HOWEVER, THE COUPLER WAS NOT INSERTED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.