GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4 EXPIRATION DATE AND UDI #, D9, H3, H4, H6, H11. H11: TWO (02) DEVICES WERE RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND OBSERVED THAT A 2.5MM COUPLER WAS RETURNED WITH NO RINGS SEATED IN THE JAW ASSEMBLY (NO SIGNS OF USE) WHILE THE OTHER COUPLER HAD BOTH RINGS SEATED IN THE JAW ASSEMBLY (SIGNS OF USE). FURTHER INSPECTION OF THE COUPLER WITH NO RINGS SEATED WAS PERFORMED AND NO DAMAGE WAS OBSERVED TO THE JAW ASSEMBLY THAT WOULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. THE SECOND COUPLER WITH THE RINGS INTACT WAS FURTHER INSPECTED. THE JAW ASSEMBLY WAS CLICKED INTO AN IN-LAB ANASTOMOTIC INSTRUMENT (AI). UPON COMPLETION OF THE APPROXIMATION, THE COUPLER RINGS DID NOT MEET THE MATING HOLES CAUSING A RING MISALIGNMENT. FURTHER REVIEW OF THE COUPLER RINGS SHOWED THAT THE LEFT COUPLER RING WAS NOT FULLY INSERTED IN THE JAW SLOT. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE RING NOT SITTING PROPERLY IN THE JAW SLOT 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 MICROVASCULAR ANASTOMOTIC COUPLER DEVICE RING ¿FALL ITSELF¿. THIS ISSUE OCCURRED PRE-OPERATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

E1: INITIAL REPORTER ADDRESS (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.