GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO D4, D9, H3, H4, H6, AND H11: H11: THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND THE LEFT RING OF THE COUPLER WAS NO LONGER SEATED IN THE JAW ASSEMBLY WHICH SUGGESTS THE DEVICE DID NOT CLOSE PROPERLY. FUNCTIONAL TESTING WAS PERFORMED, AND JAW ASSEMBLY WAS CLICKED INTO THE ANASTOMOTIC INSTRUMENT (AI) AS INTENDED. THERE WERE NO OBSERVED MALFUNCTIONS WITH THE JAW ASSEMBLY. A RING SEPARATION FORCE TEST WAS PERFORMED, AND THE DEVICE MET PRODUCT SPECIFICATIONS. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. 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.

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT A 2.5MM COUPLER FAILED TO CLOSE AND LOCK DURING AN ENT CASE. THE ISSUE WAS FURTHER DESCRIBED AS, THE SURGEONS TRIED TO USE A HEMOSTAT TO REINFORCE THE COUPLER LOCKING, AS PER THE INSTRUCTIONS FOR USE (IFU). HOWEVER, ONCE THE COUPLERS WERE DEPLOYED, THEY FAILED TO STAY CLOSED. THIS WAS OBSERVED DURING AN INTRA-OP PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.