GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

H11: THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE 2.5MM COUPLER JAW ASSEMBLY HAD BOTH COUPLER RINGS INTACT. THERE WAS NO VISIBLE DAMAGE TO THE JAW ASSEMBLY OR COUPLER RINGS THAT WOULD INDICATE THE DEVICE CONTRIBUTED TO THE ALLEGED EVENT. WHEN BROUGHT TOGETHER, THE PINS ON EACH COUPLER RING PROPERLY ALIGNED WITH THEIR MATING HOLE ON THE OPPOSING RING. THE REPORTED CONDITION WAS NOT VERIFIED. 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 A 2.5MM COUPLER POPPED OPEN AFTER CLOSURE AND CLAMPING. THE EVENT WAS FURTHER DESCRIBED AS "ANASTOMOSIS STRENGTH WAS NOT STRONG ENOUGH". THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

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