GEM MICROVASCULAR ANASTOMOTIC COUPLER

Description of Event or Problem

IT WAS REPORTED THAT ONE SIDE OF A 2.0MM COUPLER HAD "DETACHED FROM ITS INSERTION TOOL". THIS WAS OBSERVED DURING INSPECTION PRIOR TO A FREE FLAP RECONSTRUCTION PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

(B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO D9, H6 AND H11. H11: THE DEVICE WAS RECEIVED FOR EVALUATION. THE 2.0MM COUPLER JAW ASSEMBLY WAS RETURNED WITH THE RIGHT RING SEATED IN THE JAW ASSEMBLY. THE LEFT RING WAS NOT INTACT IN THE JAW ASSEMBLY AND WAS RETURNED WITHIN THE ORIGINAL TRAY. THE JAW ASSEMBLY CLICKED INTO THE ANASTOMOTIC INSTRUMENT (AI) AS INTENDED. THE KNOB OF THE AI WAS THEN ROTATED TO ENSURE THE JAW ASSEMBLY WOULD FUNCTION AS IT WOULD IN A SURGICAL PROCESS. THERE WAS NO OBSERVED MALFUNCTION WITH THE JAW ASSEMBLY. IT IS UNKNOWN IF ANY PORTION OF THE PREPARATION FOR USE OF THE COUPLER IN THE SURGICAL PROCESS MAY HAVE CONTRIBUTED TO THE ALLEGED DEFECT. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE 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.